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hCG One Step Pregnancy Test

by Sejoy Biomedical Co., Ltd. EUDAMED

Active European Union

Ref WhCG-1111,WhCG-1112,WhCG-1113,WhCG-1113a, WhCG-1113b

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number693966391HCG0002MX Basic UDI-DIDate16 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 838352 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    4 Aug 2026
    Expires
    3 Aug 2031

Specification

EUDAMED

Model / Reference
WhCG-1111, WhCG-1112, WhCG-1113, WhCG-1113a, WhCG-1113b
Primary DI / UDI-DI
06939663910569
Basic UDI-DI
693966391HCG0002MX
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000008447
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Sejoy Biomedical Co., Ltd.

See all devices from Sejoy Biomedical Co., Ltd. →

Properties

  • Microbial Substances
  • Reagent
  • Self Testing

Other properties (8)

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