Skip to content

hCG One Step Pregnancy Test Device (Urine/Serum)

by Abon Biopharm(Hangzhou) Co., Ltd

Ref FHC-202

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-06952999408371 Basic UDI-DI 06952999408371UDI-DIDate24 Nov 2023RegisteredStatusActive

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  • Withdrawn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
hCG One Step Pregnancy Test Device (Urine/Serum)
Model / Reference
FHC-202
Primary DI / UDI-DI
06952999408371
Basic UDI-DI
B-06952999408371
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000009171
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Abon Biopharm(Hangzhou) Co., Ltd

See all devices from Abon Biopharm(Hangzhou) Co., Ltd →

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