MedTechLabel WP2 T2.2 Information Model Guide
0.4.15 - ci-build
MedTechLabel WP2 T2.2 Information Model Guide
0.4.15 - ci-build
MedTechLabel WP2 T2.2 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.15 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions
| Official URL: http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement4Precoordination | Version: 0.4.15 | |||
| Active as of 2026-10-07 | Computable Name: DigitalLabelElement4PrecoordinationVS | |||
| Other Identifiers: OID:1.2.3.4.5.6.7.8.10.52 | ||||
Copyright/Legal: FO |
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pre-coordinated concepts from Digital Label Elements
References
This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement version 📦0.4.15 where concept is-a precoordinatedConcept
Expansion performed internally based on codesystem Digital Label Element v0.4.15 (CodeSystem)
This value set contains 23 concepts
| Level | System | Code | Display (en) | Inactive | Definition | status | JSON | XML |
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | precoordinatedConcept | pre-coordinated concepts | inactive | following a list of items that are a precoordination of other concepts in order to simplify the collection and indication of requirements | inactive | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | manufacturerInformation | manufacturer information | information provided by manufacturer | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | manufacturerAddress | manufacturer address | address of manufacturer | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | electronicInstruction | electronic instruction | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | electronicInterface | electronic interface | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | edocumentation | e-documentation | form of electronically accessible information supplied by the manufacturer | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | authorityHavingJurisdiction | authority having jurisdiction | governmental agency or office assigned to oversee the regulation of a regulated product within a country, jurisdiction or assigned territory | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | authorizedRepresentative | authorized representative | organization established within a country or jurisdiction who has received a written mandate from the manufacturer to act on their behalf for specified tasks regarding the latter’s obligations under that country or jurisdiction’s legislation | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | countryOfOrigin | country of origin | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | labelModelNumber | model number on label | model number on a label | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | hybridLabel | hybrid Label | label in printed and digital format | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | registeredPlaceOfBusiness | registered place of business | what is the manufacturer registered address | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | assemblerName | name of assembler | name of person that assembles the device | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | conformityAssessmentOrg | organisation performing the conformity assessment | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | conformityAssessmentOrgID | ID of organisation performing the conformity assessment | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | humanBlood | human blood | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | plasmaDerivative | plasma derivative | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | tissue | tissue | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | humanCell | human cell | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | animalCell | animal cell | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | eudamed | European Database on Medical Devices (EUDAMED) | |||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | AIsystem | AI system | |||||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | generativeAIsystem | generative AI system |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |