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High-sensitivity Cardiac Troponin I Test Kit (CLIA)

by Healgen Life Science, LLC

Ref CDHST-301a

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-10850076346253 Basic UDI-DI Date12 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  • Withdrawn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
CDHST-301a
Primary DI / UDI-DI
10850076346253, 20850076346250
Basic UDI-DI
B-10850076346253, B-20850076346250
EMDN Code
W01021306 Troponin i/t
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000043017
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Life Science LLC

See all devices from Healgen Life Science LLC →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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