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DS-EIA-IgE TOTAL

by RPC Diagnostic Systems Ltd. Russia EUDAMED

Ref ET-151/1.1

EMDN W01020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04605979402181 Basic UDI-DIDate22 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-IgE TOTAL” ENZYME IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF TOTAL IMMUNOGLOBULIN E CONCENTRATION
Model / Reference
ET-151/1.1
Primary DI / UDI-DI
04605979402181
Basic UDI-DI
B-04605979402181
EMDN Code
W01020201 Immunoglobulin e - total
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 e9b945f2-93c3-4fc3-a38e-9c4760bd18a3 61 fields · synced 22 Oct 2026