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Generic Hiv-1 Viral Load Ver 2.0

by Hain Lifescience GmbH EUDAMED

Active European Union

Ref TR001.2-192

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number40490550300001105U6 Basic UDI-DIDate4 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Model / Reference
TR001.2-192
Primary DI / UDI-DI
04049055003907
Basic UDI-DI
40490550300001105U6
EMDN Code
W0105030107 HIV 1 - na reagents
Device Class
Class D
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008606

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Properties

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