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Vitamin B12 Assay Kit（Chemiluminescence Immunoassay）

by Hunan AccuBio Biotech Co., Ltd.

Ref AB003Model 50T

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976964665897 Basic UDI-DI 06976964665897UDI-DIDate21 Oct 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  • Withdrawn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
Vitamin B12 Assay Kit（Chemiluminescence Immunoassay）
Model / Reference
50T, AB003
Primary DI / UDI-DI
06976964665897
Basic UDI-DI
B-06976964665897
EMDN Code
W0102070204 Vitamin b12
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041914
Authorised representative
Sungo Cert GmbH DE-AR-000010869

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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