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Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED

Ref HCG10-01-50t

EMDN W0102160302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6936020120BRB Basic UDI-DIDate28 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit(Colloidal Gold)
Model / Reference
HCG10-01-50t
Primary DI / UDI-DI
06936020140263
Basic UDI-DI
6936020120BRB
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Hangzhou Singclean Medical Products Co., Ltd.

See all devices from Hangzhou Singclean Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06936020140263|6936020120BRB 61 fields · synced 24 Oct 2026