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Optitrol NAT HIV Screening

by DiaMex GmbH Germany EUDAMED

Ref NT01032, NT01031 EMDN W0105080808

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426046567NTHIVScrFA 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  • Withdrawn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European Union — CE/IVDR Withdrawn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 22 Oct 2026

Model / Reference
NT01032, NT01031
Primary DI / UDI-DI
4260465670972, 4260465670965
Basic UDI-DI
426046567NTHIVScrFA
Direct Marketing DI
4260465670972
4260465670965
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 e6e325d1-8da0-4a60-8438-51f10b1188ae 61 fields · synced 22 Oct 2026
  • EUDAMED 4260465670965|426046567NTHIVSCRFA 61 fields · synced 18 May 2026