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ClinChek® Plasma Control, lyophil., for Amino Acids (by Amino Acid Analyzer), Level I, II

by RECIPE Chemicals + Instruments GmbH

Ref 10282

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-10282EX Basic UDI-DI D-10282EXUDI-DIDate7 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Plasma Control for Amino Acids (by Amino Acid Analyzer)
Model / Reference
10282
Primary DI / UDI-DI
D-10282EX
Basic UDI-DI
B-10282EX
EMDN Code
W0101050199 Multicomponent controls (cc) - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000032553

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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