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Elecsys Anti-HBs II

by Roche Diagnostics GmbH Germany EUDAMED

Ref 08498610190

EMDN W0105020203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 010283 0739 Date14 Sep 2026IssuedStatusActive expires 13 Sep 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
08498610190
Primary DI / UDI-DI
07613336160381
Basic UDI-DI
761333603413AP
EMDN Code
W0105020203 Hepatitis b surface antibody (total)
Device Class
Class D
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 e4fa462c-9a4d-411e-a8c4-959cc41f6767 61 fields · synced 23 Oct 2026