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Dr. Line hCG One Step Pregnancy Test

by Sejoy Biomedical Co., Ltd. EUDAMED

Active European Union

Ref hCG-103a

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06939663910712 Basic UDI-DIDate17 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

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.

Specification

EUDAMED

Device Name
hCG ONE STEP PREGNANCY TEST
Model / Reference
hCG-103a
Primary DI / UDI-DI
06939663910712
Basic UDI-DI
B-06939663910712
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Spain

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

  • Self Testing
  • Near-Patient Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No