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Prima Home Test

by PRIMA Lab SA Switzerland EUDAMED

Ref 800062-1CS

EMDN W0105090302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-800062-1CS4B Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HIV 1/2 Self-Test
Model / Reference
800062-1CS
Primary DI / UDI-DI
D-800062-1CS4B
Basic UDI-DI
B-800062-1CS4B
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class IVD Annex II List A
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CH-MF-000034473
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from PRIMA Lab SA

See all devices from PRIMA Lab SA →

Properties & raw data

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

Sources (1)

  • EUDAMED 96787a50-4ceb-4d54-8ef0-3000c9d632ba 61 fields · synced 24 Oct 2026