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First Response HIV 1-2.O Card Test (Version 2.0)

by Premier Medical Corporation Private Limited 2 variants

Ref PI05FRC25CEModel PI05FRC

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08906061791210 Basic UDI-DI 08906061791210UDI-DIDate23 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
HIV 1-2.O Card Test (Version 2.0)
Model / Reference
PI05FRC, PI05FRC25CE
Primary DI / UDI-DI
08906061791210
Basic UDI-DI
B-08906061791210
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class IVD Annex II List A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
IN-MF-000033197
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Premier Medical Corporation Private Limited

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Properties

  • Near-Patient Testing
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No