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Accufast

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

Ref CA01-09-422P1Model Cassette

EMDN W0102160399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976232251395 Basic UDI-DIDate3 Jul 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 23 Oct 2026

Device Name
Semi-quantitative Sperm Concentration (SP10) Rapid Test
Model / Reference
Cassette, CA01-09-422P1
Primary DI / UDI-DI
06976232251395
Basic UDI-DI
B-06976232251395
EMDN Code
W0102160399 Fertility/pregnancy rt & poc - other
Device Class
Class IVD General
Market of Registration
Germany

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 3da50e04-e491-4592-9b8d-2f868bc454f8 61 fields · synced 23 Oct 2026