Skip to content

Acmex

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

Ref CA06-10-113P100Model strip

EMDN W0102160705

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976232256079 Basic UDI-DIDate7 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Human Heart-type Fatty Acid-Binding Protein(H-FABP)Rapid Test
Model / Reference
strip, CA06-10-113P100
Primary DI / UDI-DI
06976232256079
Basic UDI-DI
B-06976232256079
EMDN Code
W0102160705 Heart-type fatty acid-binding protein - rt & poc
Device Class
Class IVD General
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
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e962d89b-324e-47fe-8ce5-ed660028a3a4 61 fields · synced 22 Oct 2026