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H&W tulehduspikatesti CRP

by PRIMA Lab SA EUDAMED

Active European Union

Ref HW-800034-1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-HW-800034-1XP Basic UDI-DIDate16 Sep 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  • Withdrawn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

Model / Reference
HW-800034-1
Primary DI / UDI-DI
D-HW-800034-1XP
Basic UDI-DI
B-HW-800034-1XP
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class IVD devices for self-testing
Market of Registration
Finland

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

  • 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