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Elecsys Anti-HEV IgG

by Roche Diagnostics GmbH Germany EUDAMED

Ref 09776737190 EMDN W0105020504

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333603453B3 Basic UDI-DIDate25 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
09776737190
Primary DI / UDI-DI
07613336219812
Basic UDI-DI
761333603453B3
EMDN Code
W0105020504 Hev antibody igg
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006260

Other devices from Roche Diagnostics GmbH

See all devices from Roche Diagnostics GmbH →

Properties & raw data

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

Sources (1)

  • EUDAMED ce73b3ae-df03-42fd-9637-8d270a61bb7f 61 fields · synced 23 Oct 2026