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SOFTEC Troponin I Rapid Test Kit

by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.

Ref SFTPIModel SFTPI40

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-08697962616275 Basic UDI-DI 08697962616275UDI-DIDate28 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  • Withdrawn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
Troponin I Rapid Test Kit
Model / Reference
SFTPI40, SFTPI
Primary DI / UDI-DI
08697962616275
Basic UDI-DI
B-08697962616275
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
TR-MF-000046897

From the manufacturer

Manufacturer's product page: RAPID TEST KITS

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Properties

  • Professional Testing

Other properties (9)

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