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BE SURE Early HCG Pregnancy Test

by Abiores Technology (Beijing) Co., Ltd. China EUDAMED

Ref ACA21A002007Model Midstream EMDN W0102160302

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-26958982110119 Basic UDI-DIDate18 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
HCG Pregnancy Tests
Model / Reference
Midstream, ACA21A002007
Primary DI / UDI-DI
26958982110119
Basic UDI-DI
B-26958982110119
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 05269a43-94f7-4ba9-b249-cf309ea91550 61 fields · synced 22 Oct 2026