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Acmex

by Acmex Bio-Technology (Chongqing) Co., Ltd. China EUDAMED

Ref CA06-02-322P25

EMDN W01021306

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697623225CA0602024W Basic UDI-DIDate16 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Cardiac Troponin I (cTnI) Rapid Test
Model / Reference
CA06-02-322P25
Primary DI / UDI-DI
06976232251906
Basic UDI-DI
697623225CA0602024W
EMDN Code
W01021306 Troponin i/t
Device Class
Class C
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000037745
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Acmex Bio-Technology (Chongqing) Co., Ltd.

See all devices from Acmex Bio-Technology (Chongqing) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • New Device
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06976232251906|697623225CA0602024W 61 fields · synced 25 Oct 2026