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HbA1c, lyophilised hemolysate Level 1

by Streekziekenhuis Koningin Beatrix 2 variants

Ref HBA-01.1_011

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-87205897081129G Basic UDI-DI Date3 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
HbA1c, Lyophilised hemolysate
Model / Reference
HBA-01.1_011
Primary DI / UDI-DI
D-87205897081129G, 87205897081128
Basic UDI-DI
B-87205897081129G, B-87205897081128
EMDN Code
W0101050205, W0101050302
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000427

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Properties

  • Human Tissues
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No