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Acmex

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

Ref CA03-19-422P25Model Cassette EMDN W0105090103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976232252019 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  • Withdrawn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 24 Oct 2026

Device Name
Group A Streptococcus (Strep A) Rapid Test
Model / Reference
Cassette, CA03-19-422P25
Primary DI / UDI-DI
06976232252019
Basic UDI-DI
B-06976232252019
EMDN Code
W0105090103 Strep. a - 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
  • Surgical Instrument
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 304d85bf-93f9-4917-83d4-4b319b5bb47b 61 fields · synced 24 Oct 2026