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ONE STEP Anti-HIV (1&2) Test

by InTec PRODUCTS, INC. EUDAMED

Active European Union

Ref ITP02153-TC40

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936155804351 Basic UDI-DIDate25 Oct 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
ONE STEP Anti-HIV (1&2) Test
Model / Reference
ITP02153-TC40
Primary DI / UDI-DI
06936155804351
Basic UDI-DI
B-06936155804351
EMDN Code
W0105030402 HIV multiple antibody
Device Class
Class IVD Annex II List A
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000023625
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from InTec PRODUCTS, INC.

See all devices from InTec PRODUCTS, INC. →

Properties

Show properties
  • Sterile
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No