<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="DeviceClass"/>
  <text>
    <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem DeviceClass</b></p><a name="DeviceClass"> </a><a name="hcDeviceClass"> </a><p>This case-sensitive code system <code>http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass</code> defines the following codes in a Is-A hierarchy:</p><table class="codes"><tr><td><b>Lvl</b></td><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td><td><b>Deutsch (German, de)</b></td></tr><tr><td>1</td><td style="white-space:nowrap">I<a name="DeviceClass-I"> </a></td><td>class I</td><td>class I (low risk)</td><td>Klasse I</td></tr><tr><td>1</td><td style="white-space:nowrap">II<a name="DeviceClass-II"> </a></td><td>class II</td><td>class II (moderate risk)</td><td>Klasse II</td></tr><tr><td>2</td><td style="white-space:nowrap">  IIa<a name="DeviceClass-IIa"> </a></td><td>class IIa</td><td>class IIa (low to moderate risk)</td><td>Klasse II</td></tr><tr><td>2</td><td style="white-space:nowrap">  IIb<a name="DeviceClass-IIb"> </a></td><td>class IIb</td><td>class IIb (moderate to high risk)</td><td>Klasse II</td></tr><tr><td>1</td><td style="white-space:nowrap">III<a name="DeviceClass-III"> </a></td><td>class III</td><td>class III (high risk)</td><td>Klasse III</td></tr></table></div>
  </text>
  <url value="http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:1.2.3.4.5.6.7.8.9.9"/>
  </identifier>
  <version value="0.4.3"/>
  <name value="DeviceClassCS"/>
  <title value="Device Class"/>
  <status value="active"/>
  <experimental value="true"/>
  <date value="2026-09-29T20:54:24+00:00"/>
  <publisher value="HL7 Europe"/>
  <contact>
    <name value="HL7 Europe"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7europe.org"/>
    </telecom>
  </contact>
  <description value="Medical devices are categorized based on their risk level, &#xA;invasiveness, and duration of contact with the body. &#xA;Regulatory bodies, such as the FDA in the US and authorities under the EU MDR."/>
  <caseSensitive value="true"/>
  <hierarchyMeaning value="is-a"/>
  <compositional value="false"/>
  <content value="complete"/>
  <count value="5"/>
  <concept>
    <code value="I"/>
    <display value="class I"/>
    <definition value="class I (low risk)"/>
    <designation>
      <language value="de"/>
      <value value="Klasse I"/>
    </designation>
  </concept>
  <concept>
    <code value="II"/>
    <display value="class II"/>
    <definition value="class II (moderate risk)"/>
    <designation>
      <language value="de"/>
      <value value="Klasse II"/>
    </designation>
    <concept>
      <code value="IIa"/>
      <display value="class IIa"/>
      <definition value="class IIa (low to moderate risk)"/>
      <designation>
        <language value="de"/>
        <value value="Klasse II"/>
      </designation>
    </concept>
    <concept>
      <code value="IIb"/>
      <display value="class IIb"/>
      <definition value="class IIb (moderate to high risk)"/>
      <designation>
        <language value="de"/>
        <value value="Klasse II"/>
      </designation>
    </concept>
  </concept>
  <concept>
    <code value="III"/>
    <display value="class III"/>
    <definition value="class III (high risk)"/>
    <designation>
      <language value="de"/>
      <value value="Klasse III"/>
    </designation>
  </concept>
</CodeSystem>