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BE SURE HCG Pregnancy Test Midstream

by Abiores Technology (Beijing) Co., Ltd.

Ref ACA21A001002Model Midstream

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-26958982110102 Basic UDI-DI 26958982110102UDI-DIDate17 Jun 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  • Withdrawn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
HCG Pregnancy Tests
Model / Reference
Midstream, ACA21A001002
Primary DI / UDI-DI
26958982110102
Basic UDI-DI
B-26958982110102
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000022952
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Abiores Technology (Beijing) Co., Ltd.

See all devices from Abiores Technology (Beijing) Co., Ltd. →

Properties

  • Reagent
  • Self Testing

Other properties (8)

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