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Optitrol NAT HBV Viral Load

by DiaMex GmbH Germany EUDAMED

Ref NT01014, NT01013 EMDN W0105080808

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426046567NTHBVVLSQ Basic UDI-DIDate19 May 2025RegisteredStatusWithdrawn

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
NT01014, NT01013
Primary DI / UDI-DI
4260465670910, 4260465670903
Basic UDI-DI
426046567NTHBVVLSQ
Direct Marketing DI
4260465670910
4260465670903
EMDN Code
W0105080808 All infectious diseases controls - nat
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000037219

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 4bd03982-2016-4eb3-b681-b837e43f3499 61 fields · synced 24 Oct 2026
  • EUDAMED 4260465670903|426046567NTHBVVLSQ 61 fields · synced 19 May 2026