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Optitrol NAT HIV-2

by DiaMex GmbH Germany EUDAMED

Ref NT01036

EMDN W0105080808

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426046567NTHIV2GG Basic UDI-DIDate14 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
NT01036
Primary DI / UDI-DI
4260465671283
Basic UDI-DI
426046567NTHIV2GG
Direct Marketing DI
4260465671283
EMDN Code
W0105080808 All infectious diseases controls - nat
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000037219

Other devices from DiaMex GmbH

See all devices from DiaMex GmbH →

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 (1)

  • EUDAMED 1135b812-527b-4830-8594-de7eae6cfdd7 61 fields · synced 22 Oct 2026