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Anti-HIV 1/2 Test

by Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. Türkiye EUDAMED

Ref RTHIV01 EMDN W0105090302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08693285181186 Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Anti-HIV 1/2 Test
Model / Reference
RTHIV01
Primary DI / UDI-DI
08693285181186
Basic UDI-DI
B-08693285181186
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class IVD Annex II List A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000028553

From the manufacturer

Manufacturer's product page: Anti-HIV 1/2 TESTİ

Other devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.

See all devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 81424913-bb62-4a4e-99a3-c7a79acde4fd 61 fields · synced 23 Oct 2026