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OraQuick HIV Self-Test

by OraSure Technologies, Inc. United States EUDAMED

Ref 1001-0630 EMDN W0105090302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-10608337001065 Basic UDI-DIDate13 May 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  • Withdrawn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 24 Oct 2026

Device Name
OraQuick HIV Self-Test, CE, Slovakia/Czech, 25 Count Kit
Model / Reference
1001-0630
Primary DI / UDI-DI
10608337001065
Basic UDI-DI
B-10608337001065
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class IVD Annex II List A
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
US-MF-000009941
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from OraSure Technologies, Inc.

See all devices from OraSure Technologies, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Self Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 10608337001065|B-10608337001065 61 fields · synced 24 Oct 2026