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HCG Pregnancy Test (Colloidal Gold)

by Anhui Deepblue Medical Technology Co., Ltd EUDAMED

Active European Union

Ref HCG1UST -2Model Cassette Strip Midstream

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06952062770695 Basic UDI-DIDate17 Jun 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06952062770695 Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Model / Reference
Cassette Strip Midstream, HCG1UST -2
Primary DI / UDI-DI
06952062770695
Basic UDI-DI
B-06952062770695, 69520627J001KW
Unit of Use DI
06952062712695
EMDN Code
W0102050205 Total human chorionic gonadotropin
Device Class
Class IVD General
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018785
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

  • Animal Tissues
  • Reagent
  • Self Testing
  • Professional Testing

Other properties (7)

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