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PRESTIGE 24i LQ CK-MB

by PZ CORMAY Spółka Akcyjna EUDAMED

Active European Union

Ref 4-427, 4-420Model PRESTIGE 24i LQ CK-MB, PRESTIGE 24i LQ CK

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514644278 Basic UDI-DIDate18 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
PRESTIGE 24i LQ CK-MB
PRESTIGE 24i LQ CK
Device Name
Ck-Mb
Ck
Model / Reference
PRESTIGE 24i LQ CK-MB, 4-427, PRESTIGE 24i LQ CK, 4-420
Primary DI / UDI-DI
05907514644278, 05907514644209
Basic UDI-DI
B-05907514644278, B-05907514644209
EMDN Code
W01010114, W01010113
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No