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B-Trol ESR Control L2

by Labquality Oy Finland EUDAMED

Ref BI0000423, BI0000422 EMDN W0103010502

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BI00004236B Basic UDI-DIDate20 Jul 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
BI0000423, BI0000422
Primary DI / UDI-DI
D-BI00004236B, D-BI000042269
Basic UDI-DI
B-BI00004236B, B-BI000042269
EMDN Code
W0103010502 Abnormal blood controls
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000019825

Properties & raw data

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

Sources (2)

  • EUDAMED 0b3e6aa2-7f48-4d94-b2ad-183e58a5ca3a 61 fields · synced 24 Oct 2026
  • EUDAMED D-BI000042269|B-BI000042269 61 fields · synced 19 May 2026