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hs-cTnI/CK-MB (CLIA)

by Drophil Biotech (Shenzhen) Company Limited

Ref 48 tests/kit:(Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-hs-cTnI/CK-MB63 Basic UDI-DI D-hs-cTnI/CK-MB63UDI-DIDate26 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  • Withdrawn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

Model / Reference
48 tests/kit:(Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)
Primary DI / UDI-DI
D-hs-cTnI/CK-MB63
Basic UDI-DI
B-hs-cTnI/CK-MB63
EMDN Code
W01021306 Troponin i/t
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000042193
Authorised representative
MedPath GmbH DE-AR-000000087

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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