Skip to content

25 Tests

by Sichuan Xincheng Biological Co LTD 7 variants

Ref T2101AW

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-06950542822100 Basic UDI-DI 06950542822100UDI-DIDate1 Sep 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  • Withdrawn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
hs-Cardiac Troponin I Assay Kit by Immunofluorescence Chromatography Method
Model / Reference
T2101AW
Primary DI / UDI-DI
06950542822100
Basic UDI-DI
B-06950542822100
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000057614
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Sichuan Xincheng Biological Co LTD

See all devices from Sichuan Xincheng Biological Co LTD →

Properties

  • Animal Tissues

Other properties (9)

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