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Bioeard BABY Early detection midstream

by Co-Innovation Biotech Co., Ltd

Ref Bioeard BABY-HCGM

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 linked in EUDAMED

A group certificate may exist

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-06970429842069 Basic UDI-DI 06970429842069UDI-DIDate12 Sep 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Biocard BABY HCG Pregnancy Test Midstream
Model / Reference
Bioeard BABY-HCGM
Primary DI / UDI-DI
06970429842069
Basic UDI-DI
B-06970429842069
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Estonia

Manufacturer details

EUDAMED SRN
CN-MF-000032023
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Co-Innovation Biotech Co., Ltd

See all devices from Co-Innovation Biotech Co., Ltd →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing

Other properties (7)

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