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autotest VIH® 2nd GENERATION

by Aaz Productions Le Materiel Biomedical 7 variants

Ref AS-VIH-001 ; AS-VIH-006 ; AS-VIH-012 ; AS-VIH-015

Active European Union

CE IVDR

Valid until

2 Jun 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier GMED SAS

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770011742ASVIH0501002U Basic UDI-DI 03401562920213UDI-DIDate26 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 40540 Active

    Technical documentation EU IVDR

    Certifier
    GMED SAS 0459
    Issued
    3 Jun 2026
    Expires
    2 Jun 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
AS-VIH-001, AS-VIH-006, AS-VIH-012, AS-VIH-015
Primary DI / UDI-DI
03401562920213
Basic UDI-DI
3770011742ASVIH0501002U
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class D
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000015889

Other devices from Aaz Productions Le Materiel Biomedical

See all devices from Aaz Productions Le Materiel Biomedical →

Properties

  • 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