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ClinChek® Serum Control, lyophil., for CDT, Level I, II

by RECIPE Chemicals + Instruments GmbH EUDAMED

Active European Union

Ref 21082

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4049195CDTCTRLV8 Basic UDI-DIDate16 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Serum Calibrator & Serum Control for CDT
Model / Reference
21082
Primary DI / UDI-DI
04049195210821
Basic UDI-DI
4049195CDTCTRLV8
Direct Marketing DI
04049195210821
EMDN Code
W0101050299 Specific controls (cc) - other
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000032553

Other devices from RECIPE Chemicals + Instruments GmbH

See all devices from RECIPE Chemicals + Instruments GmbH →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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