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DS-EIA-GONADOTROPIN-hCG

by RPC Diagnostic Systems Ltd. Russia EUDAMED

Ref RH-153/1.1 EMDN W0102050205

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04605979401573 Basic UDI-DIDate1 Oct 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
“DS-EIA-GONADOTROPIN-hCG” ENZYME IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (hCG) CONCENTRATION
Model / Reference
RH-153/1.1
Primary DI / UDI-DI
04605979401573
Basic UDI-DI
B-04605979401573
EMDN Code
W0102050205 Total human chorionic gonadotropin
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
RU-MF-000043555
Authorised representative
AB Diagnostic Systems GmbH DE-AR-000025750

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED d8064bab-2050-4dcb-9370-d20bf0dcce1e 61 fields · synced 23 Oct 2026