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Prima Home Test

by PRIMA Lab SA Switzerland EUDAMED

Ref 800060-1Model 800060-x

EMDN W01021111

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-800060-1CS3M Basic UDI-DIDate5 May 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
Streptokok a Test
Model / Reference
800060-x, 800060-1
Primary DI / UDI-DI
D-800060-1CS3M
Basic UDI-DI
B-800060-1CS3M
EMDN Code
W01021111 Anti-streptococcal screening
Device Class
Class IVD devices for self-testing
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
  • Animal Tissues
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 874442d6-616d-4e72-bbe9-ce5839cd49c8 61 fields · synced 24 Oct 2026