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hs-cTnl FIA

by Assure Tech. (Hangzhou) Co., Ltd. FDA registration: China EUDAMED

Ref hs-cTnI-W23F3 EMDN W0102160703

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16952804841130 Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
hs-cTnl FIA
Model / Reference
hs-cTnI-W23F3
Primary DI / UDI-DI
16952804841130
Basic UDI-DI
B-16952804841130
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002170
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Assure Tech. (Hangzhou) Co., Ltd.

See all devices from Assure Tech. (Hangzhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 16952804841130|B-16952804841130 61 fields · synced 24 Oct 2026