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SensiQuant PML/RARa Positive Control BCR1

by Bioclarma S.R.L. EUDAMED

Active European Union

Ref CTRL-045.1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08057723370264 Basic UDI-DIDate22 May 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
SensiQuant PML/RARa Positive Control BCR1
Model / Reference
CTRL-045.1
Primary DI / UDI-DI
08057723370264
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000030384

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