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Freely

by Gaobeidian PRISES Biotechnology Co., Ltd 5 variants

Ref HCGC30A-1TModel Cassette

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06957683732664 Basic UDI-DI 06957683732664UDI-DIDate3 Dec 2025RegisteredStatusActive

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  • Withdrawn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
One Step Early Pregnancy test kit
Model / Reference
Cassette, HCGC30A-1T
Primary DI / UDI-DI
06957683732664
Basic UDI-DI
B-06957683732664
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000035685
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Gaobeidian PRISES Biotechnology Co., Ltd

See all devices from Gaobeidian PRISES Biotechnology 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