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by Hubei MEIBAO Biotechnology Co., Ltd 3 variants

Ref 3.5mm, HCG-M35A, HCG-M40BModel HCG, Midstream

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69572903MBZYZP Basic UDI-DI Date16 Feb 2022RegisteredStatusActive
European UnionCE/IVDR Number69572903MBZYZP Basic UDI-DI Date16 Feb 2022RegisteredStatusActive

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  • Withdrawn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/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
One Step HCG Pregnancy Test
Model / Reference
HCG, 3.5mm, Midstream, HCG-M35A, HCG-M40B
Primary DI / UDI-DI
26957290300076, 06957290300201
Basic UDI-DI
69572903MBZYZP, B-26957290300076, B-06957290300201
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Class IVD devices for self-testing
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000019986
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Hubei MEIBAO Biotechnology Co., Ltd

See all devices from Hubei MEIBAO Biotechnology Co., Ltd →

Properties

  • Reagent NoEUDAMEDYesEUDAMED
  • Self Testing NoEUDAMEDYesEUDAMED

Other properties (9)

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