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Troponin I (cTnI) Rapid Test Kit (QDs Immunofluorescence Method)

by Chongqing iSIA BIO-Technology Co., Ltd. 2 variants

Ref 02WModel AFS-1000, AFS-2000A, AFS-3000B, iSIA01, iSIA02, iSIA03, iSIA01A, iSIA01B, IFC-100, cTnI-QD

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number69749697901002DR Basic UDI-DI 26974969792246UDI-DIDate12 Jun 2025RegisteredStatusActive
European UnionCE/IVDR Number69749697901002DR Basic UDI-DI 26974969792246UDI-DIDate12 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Trade Name
Troponin I (cTnI) Rapid Test Kit (QDs Immunofluorescence Method)
Troponin I Rapid Test Kit (QDs Immunofluorescence Method)
Device Name
The Immunoassay Analyzer
Model / Reference
AFS-1000, AFS-2000A, AFS-3000B, iSIA01, iSIA02, iSIA03, iSIA01A, iSIA01B, IFC-100, 02W, cTnI-QD
Primary DI / UDI-DI
26974969792246
Basic UDI-DI
69749697901002DR, B-26974969792246
EMDN Code
W0102160703, W01021306
Device Class
Class C
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003364
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Chongqing iSIA BIO-Technology Co., Ltd.

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Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (8)

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