FHIRsmith: CodeSystem/CodeSystem-DeviceClass.json

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Package	medtechlabel
Resource Type	CodeSystem
Id	CodeSystem-DeviceClass.json
FHIR Version	R4
Source	https://build.fhir.org/ig/hl7-eu/medtechlabel-wp2-im/CodeSystem-DeviceClass.html
URL	http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass
Version	0.4.7
Status	active
Date	2026-10-04T18:55:18+00:00
Name	DeviceClassCS
Title	Device Class
Authority	hl7
Description	Medical devices are categorized based on their risk level, invasiveness, and duration of contact with the body. Regulatory bodies, such as the FDA in the US and authorities under the EU MDR.
Content	complete

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Narrative

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

Generated Narrative: CodeSystem DeviceClass

This case-sensitive code system http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass defines the following codes in a Is-A hierarchy:

Lvl	Code	Display	Definition	Deutsch (German, de)
1	I	class I	class I (low risk)	Klasse I
1	II	class II	class II (moderate risk)	Klasse II
2	IIa	class IIa	class IIa (low to moderate risk)	Klasse II
2	IIb	class IIb	class IIb (moderate to high risk)	Klasse II
1	III	class III	class III (high risk)	Klasse III

Source1

{
  "resourceType": "CodeSystem",
  "id": "DeviceClass",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass",
  "identifier": [
    {
      "system": "urn:ietf:rfc:3986",
      "value": "urn:oid:1.2.3.4.5.6.7.8.9.9"
    }
  ],
  "version": "0.4.7",
  "name": "DeviceClassCS",
  "title": "Device Class",
  "status": "active",
  "experimental": true,
  "date": "2026-10-04T18:55:18+00:00",
  "publisher": "HL7 Europe",
  "contact": [
    {
      "name": "HL7 Europe",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7europe.org"
        }
      ]
    }
  ],
  "description": "Medical devices are categorized based on their risk level, \ninvasiveness, and duration of contact with the body. \nRegulatory bodies, such as the FDA in the US and authorities under the EU MDR.",
  "caseSensitive": true,
  "hierarchyMeaning": "is-a",
  "compositional": false,
  "content": "complete",
  "count": 5,
  "concept": [
    {
      "code": "I",
      "display": "class I",
      "definition": "class I (low risk)",
      "designation": [
        {
          "language": "de",
          "value": "Klasse I"
        }
      ]
    },
    {
      "code": "II",
      "display": "class II",
      "definition": "class II (moderate risk)",
      "designation": [
        {
          "language": "de",
          "value": "Klasse II"
        }
      ],
      "concept": [
        {
          "code": "IIa",
          "display": "class IIa",
          "definition": "class IIa (low to moderate risk)",
          "designation": [
            {
              "language": "de",
              "value": "Klasse II"
            }
          ]
        },
        {
          "code": "IIb",
          "display": "class IIb",
          "definition": "class IIb (moderate to high risk)",
          "designation": [
            {
              "language": "de",
              "value": "Klasse II"
            }
          ]
        }
      ]
    },
    {
      "code": "III",
      "display": "class III",
      "definition": "class III (high risk)",
      "designation": [
        {
          "language": "de",
          "value": "Klasse III"
        }
      ]
    }
  ]
}