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autotest VIH® 2nd GENERATION

by Aaz Productions Le Materiel Biomedical France EUDAMED

Ref AS-VIH-014

EMDN W0105090302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770011742ASVIH0501002U Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

Austria
  • Active
  • Not covered

European Union — CE/IVDR Active

EU market availability

Available in 1 country, as listed in EUDAMED:

  • Austria

Last checked 23 Oct 2026.

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 40540 Issued

    Technical documentation EU IVDR

    Notified body
    GMED SAS 0459
    Issued
    3 Jun 2026
    Expires
    2 Jun 2031

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AS-VIH-014
Primary DI / UDI-DI
09003622006062
Basic UDI-DI
3770011742ASVIH0501002U
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class D
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
FR-MF-000015889

Properties & raw data

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

Sources (1)

  • EUDAMED bfcb6ac6-ccb7-4a67-96f6-bdf8dd50401a 61 fields · synced 24 Oct 2026