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Acmex

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

Ref CA01-12-422P25Model Cassette EMDN W0102160399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976232251807 Basic UDI-DIDate13 Jul 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  • Withdrawn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 25 Oct 2026

Device Name
Insulin-like Growth Factor Binding Protein-1/Alpha-Fetoprotein (IGFBP-1/AFP) Combo Rapid
Model / Reference
Cassette, CA01-12-422P25
Primary DI / UDI-DI
06976232251807
Basic UDI-DI
B-06976232251807
EMDN Code
W0102160399 Fertility/pregnancy rt & poc - other
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 06976232251807|B-06976232251807 61 fields · synced 25 Oct 2026