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CRP Control POC

by Labquality Oy Finland EUDAMED

Ref BI0000128

EMDN W0102152099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BI000012866 Basic UDI-DIDate19 Aug 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
BI0000128
Primary DI / UDI-DI
D-BI000012866
Basic UDI-DI
B-BI000012866
EMDN Code
W0102152099 Controls- immunochemistry - other
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000019825

Other devices from Labquality Oy

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b2bb5066-4ceb-434b-900a-4be871d602be 61 fields · synced 25 Oct 2026