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UREA liquiUV

by Human Gesellschaft für Biochemica und Diagnostica mbH 2 variants

Ref 10521

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-04033145012788 Basic UDI-DI 04033145012788UDI-DIDate12 Oct 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-04033145012788 Basic UDI-DI 04033145012788UDI-DIDate12 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / Reference
10521
Primary DI / UDI-DI
04033145012788
Basic UDI-DI
B-04033145012788, 04033145CC10521CH
EMDN Code
W01010204 Urea/blood urea nitrogen
Device Class
Class IVD General
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025590

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No