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Total Human Chorionic Gonadotrophin-β (β-HCG) Test Kit (Immunofluorescence)

by Nanjing Norman Biological Technology Co., Ltd.

Ref 22404910500010Model 25 Tests /Box

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06921893001209 Basic UDI-DI 06921893001209UDI-DIDate2 Sep 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  • Withdrawn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

Model / Reference
25 Tests /Box, 22404910500010
Primary DI / UDI-DI
06921893001209
Basic UDI-DI
B-06921893001209
EMDN Code
W0102050206 B- human chorionic gonadotropin (incl. subunit)
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024233
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