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Ds-Eia-Steroid-Testosterone

by RPC Diagnostic Systems Ltd. Russia EUDAMED

Ref RH-353/1.1

EMDN W0102050110

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04605979401894 Basic UDI-DIDate9 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
“ds-Eia-Steroid-Testosterone” Enzyme Immunoassay for the Quantitative Determination of Testosterone Concentration
Model / Reference
RH-353/1.1
Primary DI / UDI-DI
04605979401894
Basic UDI-DI
B-04605979401894
EMDN Code
W0102050110 Testosterone (with dehydro and free testosterone)
Device Class
Class IVD General

Manufacturer details

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

Other devices from RPC Diagnostic Systems Ltd.

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 27651acb-0b17-48a6-9870-f4a844c93116 61 fields · synced 22 Oct 2026