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Packagemedtechlabel
Resource TypeCodeSystem
IdCodeSystem-DigitalLabelOntology2.json
FHIR VersionR4
Sourcehttps://build.fhir.org/ig/hl7-eu/medtechlabel-wp2-im/CodeSystem-DigitalLabelOntology2.html
URLhttp://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelOntology2
Version0.4.15
Statusactive
Date2026-10-21T08:27:53+00:00
NameDigitalLabelOntology2CS
TitleDigital Label Element Property Ontology
Authorityhl7
DescriptionOntology that supplements the **Digital Label Elements** (based on Supplement)
Contentsupplement
Supplementshttp://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement

Resources that use this resource

ValueSet
medtechlabel#currentDigitalLabelOntology2Digital Label Element Property Ontology

Resources that this resource uses

CodeSystem
medtechlabel#currentDigitalLabelElementDigital Label Element

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: CodeSystem DigitalLabelOntology2

Properties

This code system defines the following properties for its concepts

NameCodeURITypeDescriptionValue Set
has componenthasComponenthttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasComponentcodewhat is the associated component to this element? This helps to create the information model.Digital Label Element
mentionsmentionshttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#mentionscodeWhere is this information item mentioned?Digital Label Element
definesdefineshttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#definescodeWhat does this information item define?Digital Label Element
identified byidentifiedByhttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#identifiedBycodeHow is this element identified?Digital Label Element
related torelatedTohttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#relatedTocodeto which element is this item related? This helps to create the information model.Digital Label Element
partOfpartOfhttp://hl7.org/fhir/concept-properties#partOfcodepart ofDigital Label Element
has valuehasValuehttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasValuecodewhat is the specific value to use? This helps to create the information model.Digital Label Element
has formathasFormathttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasFormatcodewhat is the specific value to use? This helps to create the information model.Digital Label Element
has datatypehasDataTypehttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasDataTypecodewhat is the specific value to use? This helps to create the information model.Digital Label Element
impliesimplieshttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#impliescodewhat other element is implied by this one?Digital Label Element
applies toappliesTohttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#appliesTocodewhich other element does this one apply to?Digital Label Element
equivalent toequivalentTohttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#equivalentTocodewhich other element is this one equivalent to?Digital Label Element
identifiesidentifieshttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#identifiescodewhich other element does this one identify?Digital Label Element
is-ais-ahttp://www.hl7europe.org/medtechlabel/CodeSystem/Property#is-acodewhat is another parent element?Digital Label Element

Concepts

This code system supplement http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelOntology2 defines properties on the following codes:

LvlCodeDisplayDefinitionhas componentmentionsdefinesidentified byrelated topartOfhas valuehas formathas datatypeimpliesapplies toequivalent toidentifiesis-a
1organization organisationany kind of an organization being involvedorganizationName, address, contactInformationresponsible
1person PersonpersonpersonName, address, contactInformation
1label Labellabel for medicinal producttitle, description, icon, barcode, packagingInfo, symbolIso7010, name, tradeName, address, manufacturer, authorizedRepresentative, country, transportCondition, storageCondition, handlingCondition, specialOperatingInstruction, warning, precaution, limitation, methodOfSterilization, productionControlIdentifier, dateSafeForUse, symbolIec60417, symbolIso7000electronicInstruction, sterilesymbolIso7000-2725, symbolIso15223-5.4.10, symbolEn15986-xxx, symbolIso7000-3723, symbolIso15223-5.4.3, symbolIso7000-1641, noReuse, singleUse, symbolIso7000-1051, symbolIso15223-5.4.2, singlePatientMultipleUse, symbolIso7000-3706, symbolIso15223-5.4.12, symbolIso7000-2500, symbolIso15223-5.2.2, symbolIso7000-2501, symbolIso15223-5.2.3, symbolIso7000-2502, symbolIso15223-5.2.4, symbolIso7000-2503, symbolIso15223-5.2.5informationFormmarkingInfo, accessorymanufacturer, medicalDevice, accessory, instructionForUse, medicalDevice, accessory
2  digitalLabel digital Labellabel in electronic formatidentifier
3    printedLabel printed Labellabel in printed formatpackage, medicalDevice
1organizationName organization namename of an organizationstring
2  personName person namename of a persongivenName, familyName
2  tradeName trade nametrade name for the productregistered
2  tradeMark trade marktrade mark for the productregistered
1criticalCharacteristic critical characteristicshumanBehaviorusability, efficiency, satisfaction
1fax string
2  versionIdentifier version identifierversion identifiersoftware, medicalDevice
1txtLotNumber LOT NUMBERlabel
1txtSerialNumber SERIAL NUMBERlabel
2  manufacturerAddress manufacturer addressaddress of manufacturermanufacturer
2  electronicInstruction electronic instructionelectronic
2  electronicInterface electronic interfaceelectronic
2  countryOfOrigin country of originmanufacturer
2  authorityHavingJurisdiction authority having jurisdictiongovernmental agency or office assigned to oversee the regulation of a regulated product within a country, jurisdiction or assigned territoryjurisdiction
1registeredPlaceOfBusiness registered place of businesswhat is the manufacturer registered addressregisteredmanufacturer
1conformityAssessmentOrgID ID of organisation performing the conformity assessmentconformityAssessmentOrg, markCE
2  assemblerName name of assemblername of person that assembles the deviceassembling
2  humanBlood human bloodhumanOrigin
2  plasmaDerivative plasma derivativehumanOrigin
2  tissue tissuehumanOrigin
2  humanCell human cellhumanOrigin
2  animalCell animal cellhumanOrigin
2  eudamed EUDAMEDorganization
1standard standardiso3166, iso7000, iso7010, iso14971, iso15223, iec60417, iso80000, iso14971, accessory, accompanyingInfo, applicablePolicy, havingJurisdiction, authorizedRepresentative, catalogNumber, productName, productCode, distributor, edocumentation, expectedLifeTime, importer, safetyInfo, manufacturerInformation, instructionForUse, label, layUser, lot, lotNumber, markingInfo, medicalDevice, deviceFamily, modelNumber, multiplePatientMultipleUse, normalUse, organization, patient, subjectOfCare, pictogram, procedure, symbolIso7010, serialNumber, servicePersonnel, shelfLife, singlePatientMultipleUse, singleUse, stability, sterile, symbol, technicalDescription, udi, usability, usability, environment, useSpecification, userType, country, date, address, modelNumber, catalogNumber, identifier, multipleUse, sterilemanufacturerInformation, label, shelfLife, singlePatientMultipleUse, singleUse, stability, sterile, symbol, technicalDescription, udi, environment, useSpecification, modelNumberriskManagement, addtlInfo
1medicalDevice accessory, accompanyingInfo, label, sizecatalogNumber, udi, catalogNumber, modelNumber, sterile, methodOfSterilization, sterileBarrierConfiguration, modelNumber, catalogNumberlot
1accessory catalogNumberudiconsumableComponent, medicalDevice, sparePart
1manufacturer languagesymbolIso15223-5.1.1, authorizedRepresentativeedocumentation
1accompanyingInfo label, marking, instructionForUse, technicalDescription, information, installationManual, quickReferenceGuide, installing, instructionForUse, technicalDescription, modelNumber, catalogNumber, description, edocumentationelectronic, cdrom, dvd, usb, websiteskill, training, knowledgemedicalDevice, manufacturer, deviceFamily
1edocumentation manufacturerInformation
1applicablePolicy requirement, format
1authority applicablePolicy
1authorizedRepresentative symbolToIdentify
1catalogNumber symbolsymbolIso7000-2493, symbolIso15223-5.1.6productCode, stringFormatspecificationmanufacturing
1product productCode, catalogNumber, lotNumber, serialNumber, dateSafeForUse, productionDatedistributor
1readability person, person
1distributor importer, manufacturer, importer
1stability medicalDevice, sterile, transport, storing
1expectedLifeTime absoluteExpectedLifeTime, relativeExpectedLifeTimemaintaining, repairingexpectedServiceTime
1importer organization
1riskManagement riskControlMeasure, hazard
1safetyInfo warning, error, informationriskManagement
1instructionForUse specialOperatingInstruction, warning, accompanyingInfo, intendedUse, safetyInfo, residualRisk, contraIndicationroleUser, safetyInfosafetyInfo
1information safetyInfo, conditionprinted, symboljustification
1manufacturerInformation edocumentation, shippingDocument, packagingListmedicalDevice, safetyInfo
1userType layUser, professional, person, healthProfessional, servicePersonnel, patientpatient
1lot lotNumbercondition, manufacturing, date
1markingInfo legibleformatriskdurableThruLifetime, durableThruShelfLife
1purpose diagnostics, prevention, monitoring, alleviationOfDisease, investigation
1normalUse maintaining, transport, error
1subjectOfCare person
1procedure preparing, sterilizing
1symbol symbolIso7010
1serialNumber symbolIso15223symbolIso7000stringFormat, symbol, stringFormatuniqueNumber
1singleUse noReuse
1technicalDescription installing, preparing, maintaining, repairing, transport, instructionForUse
1udi barcode
1environment conditioncondition, useEnvironment
1useSpecification environmentintendedUse
1unit unitSI
1symbolToIdentify iso7000, iso7010, iso15223, iec60417, iec60878
1language code, stringFormat
1country countryCode, countryCodecode, stringFormat, string, code
1date dateYYYYMMDD, dateYYYYMM, dateYYYY
1address street, number, city, state, region, postalCode, country
1modelNumber catalogNumbercatalogNumber, singleUse, singlePatientMultipleUse, multiplePatientMultipleUse
1identifier uniqueNumber
1jurisdiction countryOfOrigin
1labelModelNumber symbolIec60417-6050stringFormat
1lotNumber symbolIso7000, symbolIso15223stringFormat, symbol, stringFormat
1productionControlIdentifier serialNumber, donorIdentifierserialNumber
1dateSafeForUse symbolIso7000
1productionDate symbolIso7000
1packagingInfo authorizedRepresentative, intendedUsenoReuse, singleUse, symbolIso7000, singlePatientMultipleUsetradeName, address
1residualRisk limitation, contraIndication, precaution, warning

Source1

{
  "resourceType": "CodeSystem",
  "id": "DigitalLabelOntology2",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelOntology2",
  "version": "0.4.15",
  "name": "DigitalLabelOntology2CS",
  "title": "Digital Label Element Property Ontology",
  "status": "active",
  "experimental": true,
  "date": "2026-10-21T08:27:53+00:00",
  "publisher": "HL7 Europe",
  "contact": [
    {
      "name": "HL7 Europe",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7europe.org"
        }
      ]
    }
  ],
  "description": "Ontology that supplements the **Digital Label Elements** (based on Supplement)",
  "compositional": false,
  "content": "supplement",
  "supplements": "http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement",
  "property": [
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "hasComponent",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasComponent",
      "description": "what is the associated component to this element? This helps to create the information model.",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "mentions",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#mentions",
      "description": "Where is this information item mentioned?",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "defines",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#defines",
      "description": "What does this information item define?",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "identifiedBy",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#identifiedBy",
      "description": "How is this element identified?",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "relatedTo",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#relatedTo",
      "description": "to which element is this item related? This helps to create the information model.",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "partOf",
      "uri": "http://hl7.org/fhir/concept-properties#partOf",
      "description": "part of",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "hasValue",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasValue",
      "description": "what is the specific value to use? This helps to create the information model.",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "hasFormat",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasFormat",
      "description": "what is the specific value to use? This helps to create the information model.",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "hasDataType",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasDataType",
      "description": "what is the specific value to use? This helps to create the information model.",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "implies",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#implies",
      "description": "what other element is implied by this one?",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "appliesTo",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#appliesTo",
      "description": "which other element does this one apply to?",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "equivalentTo",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#equivalentTo",
      "description": "which other element is this one equivalent to?",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "identifies",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#identifies",
      "description": "which other element does this one identify?",
      "type": "code"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/codesystem-property-valueset",
          "valueCanonical": "http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement"
        }
      ],
      "code": "is-a",
      "uri": "http://www.hl7europe.org/medtechlabel/CodeSystem/Property#is-a",
      "description": "what is another parent element?",
      "type": "code"
    }
  ],
  "concept": [
    {
      "code": "organization",
      "display": "organisation",
      "definition": "any kind of an organization being involved",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "organizationName"
        },
        {
          "code": "hasComponent",
          "valueCode": "address"
        },
        {
          "code": "hasComponent",
          "valueCode": "contactInformation"
        },
        {
          "code": "implies",
          "valueCode": "responsible"
        }
      ]
    },
    {
      "code": "person",
      "display": "Person",
      "definition": "person",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "personName"
        },
        {
          "code": "hasComponent",
          "valueCode": "address"
        },
        {
          "code": "hasComponent",
          "valueCode": "contactInformation"
        }
      ]
    },
    {
      "code": "label",
      "display": "Label",
      "definition": "label for medicinal product",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "title"
        },
        {
          "code": "hasComponent",
          "valueCode": "description"
        },
        {
          "code": "hasComponent",
          "valueCode": "icon"
        },
        {
          "code": "hasComponent",
          "valueCode": "barcode"
        },
        {
          "code": "hasComponent",
          "valueCode": "packagingInfo"
        },
        {
          "code": "implies",
          "valueCode": "markingInfo"
        },
        {
          "code": "implies",
          "valueCode": "accessory"
        },
        {
          "code": "hasFormat",
          "valueCode": "informationForm"
        },
        {
          "code": "identifies",
          "valueCode": "manufacturer"
        },
        {
          "code": "identifies",
          "valueCode": "medicalDevice"
        },
        {
          "code": "identifies",
          "valueCode": "accessory"
        },
        {
          "code": "identifies",
          "valueCode": "instructionForUse"
        },
        {
          "code": "hasComponent",
          "valueCode": "symbolIso7010"
        },
        {
          "code": "hasComponent",
          "valueCode": "name"
        },
        {
          "code": "hasComponent",
          "valueCode": "tradeName"
        },
        {
          "code": "hasComponent",
          "valueCode": "address"
        },
        {
          "code": "hasComponent",
          "valueCode": "manufacturer"
        },
        {
          "code": "hasComponent",
          "valueCode": "authorizedRepresentative"
        },
        {
          "code": "hasComponent",
          "valueCode": "country"
        },
        {
          "code": "identifies",
          "valueCode": "medicalDevice"
        },
        {
          "code": "identifies",
          "valueCode": "accessory"
        },
        {
          "code": "hasComponent",
          "valueCode": "transportCondition"
        },
        {
          "code": "hasComponent",
          "valueCode": "storageCondition"
        },
        {
          "code": "hasComponent",
          "valueCode": "handlingCondition"
        },
        {
          "code": "hasComponent",
          "valueCode": "specialOperatingInstruction"
        },
        {
          "code": "hasComponent",
          "valueCode": "warning"
        },
        {
          "code": "hasComponent",
          "valueCode": "precaution"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-2725"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.4.10"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolEn15986-xxx"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-3723"
        },
        {
          "code": "mentions",
          "valueCode": "electronicInstruction"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.4.3"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-1641"
        },
        {
          "code": "hasValue",
          "valueCode": "noReuse"
        },
        {
          "code": "hasValue",
          "valueCode": "singleUse"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-1051"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.4.2"
        },
        {
          "code": "hasValue",
          "valueCode": "singlePatientMultipleUse"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-3706"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.4.12"
        },
        {
          "code": "hasComponent",
          "valueCode": "limitation"
        },
        {
          "code": "mentions",
          "valueCode": "sterile"
        },
        {
          "code": "hasComponent",
          "valueCode": "methodOfSterilization"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-2500"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.2.2"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-2501"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.2.3"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-2502"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.2.4"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000-2503"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223-5.2.5"
        },
        {
          "code": "hasComponent",
          "valueCode": "productionControlIdentifier"
        },
        {
          "code": "hasComponent",
          "valueCode": "dateSafeForUse"
        },
        {
          "code": "hasComponent",
          "valueCode": "symbolIec60417"
        },
        {
          "code": "hasComponent",
          "valueCode": "symbolIso7000"
        }
      ],
      "concept": [
        {
          "code": "digitalLabel",
          "display": "digital Label",
          "definition": "label in electronic format",
          "property": [
            {
              "code": "hasComponent",
              "valueCode": "identifier"
            }
          ],
          "concept": [
            {
              "code": "printedLabel",
              "display": "printed Label",
              "definition": "label in printed format",
              "property": [
                {
                  "code": "relatedTo",
                  "valueCode": "package"
                },
                {
                  "code": "relatedTo",
                  "valueCode": "medicalDevice"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "code": "organizationName",
      "display": "organization name",
      "definition": "name of an organization",
      "property": [
        {
          "code": "hasDataType",
          "valueCode": "string"
        }
      ],
      "concept": [
        {
          "code": "personName",
          "display": "person name",
          "definition": "name of a person",
          "property": [
            {
              "code": "hasComponent",
              "valueCode": "givenName"
            },
            {
              "code": "hasComponent",
              "valueCode": "familyName"
            }
          ]
        },
        {
          "code": "tradeName",
          "display": "trade name",
          "definition": "trade name for the product",
          "property": [
            {
              "code": "relatedTo",
              "valueCode": "registered"
            }
          ]
        },
        {
          "code": "tradeMark",
          "display": "trade mark",
          "definition": "trade mark for the product",
          "property": [
            {
              "code": "relatedTo",
              "valueCode": "registered"
            }
          ]
        }
      ]
    },
    {
      "code": "criticalCharacteristic",
      "display": "critical characteristics",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "usability"
        },
        {
          "code": "hasValue",
          "valueCode": "efficiency"
        },
        {
          "code": "hasValue",
          "valueCode": "satisfaction"
        },
        {
          "code": "hasComponent",
          "valueCode": "humanBehavior"
        }
      ]
    },
    {
      "code": "fax",
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        {
          "code": "hasDataType",
          "valueCode": "string"
        }
      ],
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        {
          "code": "versionIdentifier",
          "display": "version identifier",
          "definition": "version identifier",
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            {
              "code": "relatedTo",
              "valueCode": "software"
            },
            {
              "code": "relatedTo",
              "valueCode": "medicalDevice"
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          ]
        }
      ]
    },
    {
      "code": "txtLotNumber",
      "display": "LOT NUMBER",
      "property": [
        {
          "code": "partOf",
          "valueCode": "label"
        }
      ]
    },
    {
      "code": "txtSerialNumber",
      "display": "SERIAL NUMBER",
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        {
          "code": "partOf",
          "valueCode": "label"
        }
      ],
      "concept": [
        {
          "code": "manufacturerAddress",
          "display": "manufacturer address",
          "definition": "address of manufacturer",
          "property": [
            {
              "code": "hasComponent",
              "valueCode": "manufacturer"
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          ]
        },
        {
          "code": "electronicInstruction",
          "display": "electronic instruction",
          "property": [
            {
              "code": "relatedTo",
              "valueCode": "electronic"
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          ]
        },
        {
          "code": "electronicInterface",
          "display": "electronic interface",
          "property": [
            {
              "code": "relatedTo",
              "valueCode": "electronic"
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          ]
        },
        {
          "code": "countryOfOrigin",
          "display": "country of origin",
          "property": [
            {
              "code": "relatedTo",
              "valueCode": "manufacturer"
            }
          ]
        },
        {
          "code": "authorityHavingJurisdiction",
          "display": "authority having jurisdiction",
          "definition": "governmental agency or office assigned to oversee the regulation of a regulated product within a country, jurisdiction or assigned territory",
          "property": [
            {
              "code": "hasComponent",
              "valueCode": "jurisdiction"
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          ]
        }
      ]
    },
    {
      "code": "registeredPlaceOfBusiness",
      "display": "registered place of business",
      "definition": "what is the manufacturer registered address",
      "property": [
        {
          "code": "partOf",
          "valueCode": "manufacturer"
        },
        {
          "code": "relatedTo",
          "valueCode": "registered"
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      ]
    },
    {
      "code": "conformityAssessmentOrgID",
      "display": "ID of organisation performing the conformity assessment",
      "property": [
        {
          "code": "partOf",
          "valueCode": "conformityAssessmentOrg"
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        {
          "code": "partOf",
          "valueCode": "markCE"
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      ],
      "concept": [
        {
          "code": "assemblerName",
          "display": "name of assembler",
          "definition": "name of person that assembles the device",
          "property": [
            {
              "code": "relatedTo",
              "valueCode": "assembling"
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          ]
        },
        {
          "code": "humanBlood",
          "display": "human blood",
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            {
              "code": "relatedTo",
              "valueCode": "humanOrigin"
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          ]
        },
        {
          "code": "plasmaDerivative",
          "display": "plasma derivative",
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            {
              "code": "relatedTo",
              "valueCode": "humanOrigin"
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          ]
        },
        {
          "code": "tissue",
          "display": "tissue",
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            {
              "code": "relatedTo",
              "valueCode": "humanOrigin"
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          ]
        },
        {
          "code": "humanCell",
          "display": "human cell",
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            {
              "code": "relatedTo",
              "valueCode": "humanOrigin"
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          ]
        },
        {
          "code": "animalCell",
          "display": "animal cell",
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            {
              "code": "relatedTo",
              "valueCode": "humanOrigin"
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          ]
        },
        {
          "code": "eudamed",
          "display": "EUDAMED",
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            {
              "code": "relatedTo",
              "valueCode": "organization"
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          ]
        }
      ]
    },
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      "code": "standard",
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        {
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        {
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        {
          "code": "mentions",
          "valueCode": "iso14971"
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        {
          "code": "mentions",
          "valueCode": "iso15223"
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        {
          "code": "mentions",
          "valueCode": "iec60417"
        },
        {
          "code": "mentions",
          "valueCode": "iso80000"
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        {
          "code": "mentions",
          "valueCode": "iso14971"
        },
        {
          "code": "mentions",
          "valueCode": "accessory"
        },
        {
          "code": "mentions",
          "valueCode": "accompanyingInfo"
        },
        {
          "code": "mentions",
          "valueCode": "applicablePolicy"
        },
        {
          "code": "mentions",
          "valueCode": "havingJurisdiction"
        },
        {
          "code": "mentions",
          "valueCode": "authorizedRepresentative"
        },
        {
          "code": "mentions",
          "valueCode": "catalogNumber"
        },
        {
          "code": "mentions",
          "valueCode": "productName"
        },
        {
          "code": "mentions",
          "valueCode": "productCode"
        },
        {
          "code": "mentions",
          "valueCode": "distributor"
        },
        {
          "code": "mentions",
          "valueCode": "edocumentation"
        },
        {
          "code": "mentions",
          "valueCode": "expectedLifeTime"
        },
        {
          "code": "hasComponent",
          "valueCode": "standard"
        },
        {
          "code": "mentions",
          "valueCode": "importer"
        },
        {
          "code": "mentions",
          "valueCode": "safetyInfo"
        },
        {
          "code": "mentions",
          "valueCode": "manufacturerInformation"
        },
        {
          "code": "defines",
          "valueCode": "manufacturerInformation"
        },
        {
          "code": "mentions",
          "valueCode": "instructionForUse"
        },
        {
          "code": "mentions",
          "valueCode": "label"
        },
        {
          "code": "defines",
          "valueCode": "label"
        },
        {
          "code": "mentions",
          "valueCode": "layUser"
        },
        {
          "code": "mentions",
          "valueCode": "lot"
        },
        {
          "code": "mentions",
          "valueCode": "lotNumber"
        },
        {
          "code": "mentions",
          "valueCode": "markingInfo"
        },
        {
          "code": "mentions",
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        {
          "code": "mentions",
          "valueCode": "deviceFamily"
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        {
          "code": "mentions",
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        {
          "code": "mentions",
          "valueCode": "multiplePatientMultipleUse"
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        {
          "code": "mentions",
          "valueCode": "normalUse"
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        {
          "code": "mentions",
          "valueCode": "organization"
        },
        {
          "code": "mentions",
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        {
          "code": "mentions",
          "valueCode": "subjectOfCare"
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        {
          "code": "mentions",
          "valueCode": "pictogram"
        },
        {
          "code": "mentions",
          "valueCode": "procedure"
        },
        {
          "code": "mentions",
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        {
          "code": "mentions",
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        {
          "code": "mentions",
          "valueCode": "servicePersonnel"
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        {
          "code": "mentions",
          "valueCode": "shelfLife"
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        {
          "code": "defines",
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        {
          "code": "mentions",
          "valueCode": "singlePatientMultipleUse"
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        {
          "code": "defines",
          "valueCode": "singlePatientMultipleUse"
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        {
          "code": "mentions",
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        {
          "code": "defines",
          "valueCode": "singleUse"
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        {
          "code": "mentions",
          "valueCode": "stability"
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        {
          "code": "defines",
          "valueCode": "stability"
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        {
          "code": "mentions",
          "valueCode": "sterile"
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        {
          "code": "defines",
          "valueCode": "sterile"
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        {
          "code": "mentions",
          "valueCode": "symbol"
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        {
          "code": "defines",
          "valueCode": "symbol"
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        {
          "code": "mentions",
          "valueCode": "technicalDescription"
        },
        {
          "code": "defines",
          "valueCode": "technicalDescription"
        },
        {
          "code": "mentions",
          "valueCode": "udi"
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        {
          "code": "defines",
          "valueCode": "udi"
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        {
          "code": "mentions",
          "valueCode": "usability"
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        {
          "code": "mentions",
          "valueCode": "usability"
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        {
          "code": "mentions",
          "valueCode": "environment"
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        {
          "code": "defines",
          "valueCode": "environment"
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        {
          "code": "mentions",
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        {
          "code": "defines",
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        {
          "code": "mentions",
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        {
          "code": "implies",
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        {
          "code": "implies",
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        {
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        {
          "code": "mentions",
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        {
          "code": "mentions",
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        {
          "code": "mentions",
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        {
          "code": "defines",
          "valueCode": "modelNumber"
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        {
          "code": "mentions",
          "valueCode": "catalogNumber"
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        {
          "code": "mentions",
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        {
          "code": "mentions",
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        {
          "code": "mentions",
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      ]
    },
    {
      "code": "medicalDevice",
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        {
          "code": "hasComponent",
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        {
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        {
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        {
          "code": "identifiedBy",
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        {
          "code": "identifiedBy",
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        {
          "code": "identifiedBy",
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        {
          "code": "identifiedBy",
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        {
          "code": "identifiedBy",
          "valueCode": "methodOfSterilization"
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        {
          "code": "identifiedBy",
          "valueCode": "sterileBarrierConfiguration"
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        {
          "code": "identifiedBy",
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        {
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    },
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        {
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      "code": "manufacturer",
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        {
          "code": "mentions",
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        {
          "code": "identifiedBy",
          "valueCode": "symbolIso15223-5.1.1"
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      "code": "accompanyingInfo",
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        {
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        {
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        {
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        {
          "code": "hasComponent",
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        {
          "code": "hasComponent",
          "valueCode": "quickReferenceGuide"
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        {
          "code": "hasComponent",
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        {
          "code": "hasFormat",
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        {
          "code": "hasFormat",
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        {
          "code": "hasFormat",
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        {
          "code": "hasFormat",
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        {
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        {
          "code": "hasComponent",
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    },
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      "code": "edocumentation",
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        {
          "code": "hasComponent",
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      "code": "applicablePolicy",
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        {
          "code": "defines",
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        {
          "code": "defines",
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    },
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      "code": "authorizedRepresentative",
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        {
          "code": "hasFormat",
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          "code": "hasValue",
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    },
    {
      "code": "product",
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        {
          "code": "identifiedBy",
          "valueCode": "productCode"
        },
        {
          "code": "identifiedBy",
          "valueCode": "catalogNumber"
        },
        {
          "code": "hasValue",
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        },
        {
          "code": "identifiedBy",
          "valueCode": "lotNumber"
        },
        {
          "code": "identifiedBy",
          "valueCode": "serialNumber"
        },
        {
          "code": "identifiedBy",
          "valueCode": "dateSafeForUse"
        },
        {
          "code": "identifiedBy",
          "valueCode": "productionDate"
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      ]
    },
    {
      "code": "readability",
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        {
          "code": "appliesTo",
          "valueCode": "person"
        },
        {
          "code": "appliesTo",
          "valueCode": "person"
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      ]
    },
    {
      "code": "distributor",
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        {
          "code": "is-a",
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        },
        {
          "code": "is-a",
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        },
        {
          "code": "is-a",
          "valueCode": "importer"
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      ]
    },
    {
      "code": "stability",
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        {
          "code": "constrains",
          "valueCode": "expectedLifeTime"
        },
        {
          "code": "appliesTo",
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        },
        {
          "code": "appliesTo",
          "valueCode": "sterile"
        },
        {
          "code": "appliesTo",
          "valueCode": "transport"
        },
        {
          "code": "appliesTo",
          "valueCode": "storing"
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      ]
    },
    {
      "code": "expectedLifeTime",
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        {
          "code": "equivalentTo",
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        },
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          "code": "implies",
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        },
        {
          "code": "implies",
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        },
        {
          "code": "hasValue",
          "valueCode": "absoluteExpectedLifeTime"
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        {
          "code": "hasValue",
          "valueCode": "relativeExpectedLifeTime"
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      ]
    },
    {
      "code": "importer",
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        {
          "code": "is-a",
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      ]
    },
    {
      "code": "riskManagement",
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        {
          "code": "hasComponent",
          "valueCode": "riskControlMeasure"
        },
        {
          "code": "hasComponent",
          "valueCode": "hazard"
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      ]
    },
    {
      "code": "safetyInfo",
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        {
          "code": "implies",
          "valueCode": "riskManagement"
        },
        {
          "code": "hasValue",
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        {
          "code": "hasValue",
          "valueCode": "error"
        },
        {
          "code": "hasValue",
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    },
    {
      "code": "instructionForUse",
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        {
          "code": "is-a",
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        {
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        },
        {
          "code": "implies",
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        },
        {
          "code": "hasComponent",
          "valueCode": "specialOperatingInstruction"
        },
        {
          "code": "hasComponent",
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        },
        {
          "code": "hasComponent",
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        },
        {
          "code": "hasComponent",
          "valueCode": "intendedUse"
        },
        {
          "code": "hasComponent",
          "valueCode": "safetyInfo"
        },
        {
          "code": "hasComponent",
          "valueCode": "residualRisk"
        },
        {
          "code": "hasComponent",
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      ]
    },
    {
      "code": "information",
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        {
          "code": "hasComponent",
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        },
        {
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        {
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        {
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        {
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      ]
    },
    {
      "code": "manufacturerInformation",
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        {
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        {
          "code": "hasComponent",
          "valueCode": "shippingDocument"
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        {
          "code": "hasComponent",
          "valueCode": "packagingList"
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        {
          "code": "identifies",
          "valueCode": "medicalDevice"
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        {
          "code": "identifies",
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      ]
    },
    {
      "code": "userType",
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        {
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        {
          "code": "hasValue",
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        {
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        {
          "code": "hasValue",
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        {
          "code": "hasValue",
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        {
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        {
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    },
    {
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        {
          "code": "implies",
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        {
          "code": "implies",
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        {
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    },
    {
      "code": "markingInfo",
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        {
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        {
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        {
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        {
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      ]
    },
    {
      "code": "purpose",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "diagnostics"
        },
        {
          "code": "hasValue",
          "valueCode": "prevention"
        },
        {
          "code": "hasValue",
          "valueCode": "monitoring"
        },
        {
          "code": "hasValue",
          "valueCode": "alleviationOfDisease"
        },
        {
          "code": "hasValue",
          "valueCode": "investigation"
        }
      ]
    },
    {
      "code": "normalUse",
      "property": [
        {
          "code": "implies",
          "valueCode": "maintaining"
        },
        {
          "code": "implies",
          "valueCode": "transport"
        },
        {
          "code": "implies",
          "valueCode": "error"
        }
      ]
    },
    {
      "code": "subjectOfCare",
      "property": [
        {
          "code": "is-a",
          "valueCode": "person"
        }
      ]
    },
    {
      "code": "procedure",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "preparing"
        },
        {
          "code": "hasValue",
          "valueCode": "sterilizing"
        }
      ]
    },
    {
      "code": "symbol",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "symbolIso7010"
        }
      ]
    },
    {
      "code": "serialNumber",
      "property": [
        {
          "code": "is-a",
          "valueCode": "uniqueNumber"
        },
        {
          "code": "hasFormat",
          "valueCode": "stringFormat"
        },
        {
          "code": "hasFormat",
          "valueCode": "symbol"
        },
        {
          "code": "hasFormat",
          "valueCode": "stringFormat"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000"
        },
        {
          "code": "hasComponent",
          "valueCode": "symbolIso15223"
        }
      ]
    },
    {
      "code": "singleUse",
      "property": [
        {
          "code": "equivalentTo",
          "valueCode": "noReuse"
        }
      ]
    },
    {
      "code": "technicalDescription",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "installing"
        },
        {
          "code": "hasComponent",
          "valueCode": "preparing"
        },
        {
          "code": "hasComponent",
          "valueCode": "maintaining"
        },
        {
          "code": "hasComponent",
          "valueCode": "repairing"
        },
        {
          "code": "hasComponent",
          "valueCode": "transport"
        },
        {
          "code": "hasComponent",
          "valueCode": "instructionForUse"
        }
      ]
    },
    {
      "code": "udi",
      "property": [
        {
          "code": "hasFormat",
          "valueCode": "barcode"
        }
      ]
    },
    {
      "code": "environment",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "condition"
        },
        {
          "code": "hasValue",
          "valueCode": "condition"
        },
        {
          "code": "hasValue",
          "valueCode": "useEnvironment"
        }
      ]
    },
    {
      "code": "useSpecification",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "environment"
        },
        {
          "code": "mentions",
          "valueCode": "intendedUse"
        }
      ]
    },
    {
      "code": "unit",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "unitSI"
        }
      ]
    },
    {
      "code": "symbolToIdentify",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "iso7000"
        },
        {
          "code": "hasValue",
          "valueCode": "iso7010"
        },
        {
          "code": "hasValue",
          "valueCode": "iso15223"
        },
        {
          "code": "hasValue",
          "valueCode": "iec60417"
        },
        {
          "code": "hasValue",
          "valueCode": "iec60878"
        }
      ]
    },
    {
      "code": "language",
      "property": [
        {
          "code": "hasFormat",
          "valueCode": "code"
        },
        {
          "code": "hasFormat",
          "valueCode": "stringFormat"
        }
      ]
    },
    {
      "code": "country",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "countryCode"
        },
        {
          "code": "hasFormat",
          "valueCode": "code"
        },
        {
          "code": "hasFormat",
          "valueCode": "stringFormat"
        },
        {
          "code": "hasFormat",
          "valueCode": "string"
        },
        {
          "code": "hasFormat",
          "valueCode": "code"
        },
        {
          "code": "hasValue",
          "valueCode": "countryCode"
        }
      ]
    },
    {
      "code": "date",
      "property": [
        {
          "code": "hasFormat",
          "valueCode": "dateYYYYMMDD"
        },
        {
          "code": "hasFormat",
          "valueCode": "dateYYYYMM"
        },
        {
          "code": "hasFormat",
          "valueCode": "dateYYYY"
        }
      ]
    },
    {
      "code": "address",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "street"
        },
        {
          "code": "hasComponent",
          "valueCode": "number"
        },
        {
          "code": "hasComponent",
          "valueCode": "city"
        },
        {
          "code": "hasComponent",
          "valueCode": "state"
        },
        {
          "code": "hasComponent",
          "valueCode": "region"
        },
        {
          "code": "hasComponent",
          "valueCode": "postalCode"
        },
        {
          "code": "hasComponent",
          "valueCode": "country"
        }
      ]
    },
    {
      "code": "modelNumber",
      "property": [
        {
          "code": "equivalentTo",
          "valueCode": "catalogNumber"
        },
        {
          "code": "hasValue",
          "valueCode": "catalogNumber"
        },
        {
          "code": "equivalentTo",
          "valueCode": "singleUse"
        },
        {
          "code": "equivalentTo",
          "valueCode": "singlePatientMultipleUse"
        },
        {
          "code": "equivalentTo",
          "valueCode": "multiplePatientMultipleUse"
        }
      ]
    },
    {
      "code": "identifier",
      "property": [
        {
          "code": "is-a",
          "valueCode": "uniqueNumber"
        }
      ]
    },
    {
      "code": "jurisdiction",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "countryOfOrigin"
        }
      ]
    },
    {
      "code": "labelModelNumber",
      "property": [
        {
          "code": "hasFormat",
          "valueCode": "stringFormat"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIec60417-6050"
        }
      ]
    },
    {
      "code": "lotNumber",
      "property": [
        {
          "code": "hasFormat",
          "valueCode": "stringFormat"
        },
        {
          "code": "hasFormat",
          "valueCode": "symbol"
        },
        {
          "code": "hasFormat",
          "valueCode": "stringFormat"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso15223"
        }
      ]
    },
    {
      "code": "productionControlIdentifier",
      "property": [
        {
          "code": "is-a",
          "valueCode": "serialNumber"
        },
        {
          "code": "equivalentTo",
          "valueCode": "serialNumber"
        },
        {
          "code": "equivalentTo",
          "valueCode": "donorIdentifier"
        }
      ]
    },
    {
      "code": "dateSafeForUse",
      "property": [
        {
          "code": "identifiedBy",
          "valueCode": "symbolIso7000"
        }
      ]
    },
    {
      "code": "productionDate",
      "property": [
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000"
        }
      ]
    },
    {
      "code": "packagingInfo",
      "property": [
        {
          "code": "identifies",
          "valueCode": "tradeName"
        },
        {
          "code": "identifies",
          "valueCode": "address"
        },
        {
          "code": "hasComponent",
          "valueCode": "authorizedRepresentative"
        },
        {
          "code": "hasValue",
          "valueCode": "noReuse"
        },
        {
          "code": "hasValue",
          "valueCode": "singleUse"
        },
        {
          "code": "hasValue",
          "valueCode": "symbolIso7000"
        },
        {
          "code": "hasValue",
          "valueCode": "singlePatientMultipleUse"
        },
        {
          "code": "hasComponent",
          "valueCode": "intendedUse"
        }
      ]
    },
    {
      "code": "residualRisk",
      "property": [
        {
          "code": "hasComponent",
          "valueCode": "limitation"
        },
        {
          "code": "hasComponent",
          "valueCode": "contraIndication"
        },
        {
          "code": "hasComponent",
          "valueCode": "precaution"
        },
        {
          "code": "hasComponent",
          "valueCode": "warning"
        }
      ]
    }
  ]
}