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EnterovirusV71+Coxsackievirus A16 Combo Test

by Zhuhai Encode Medical Engineering Co., Ltd. China EUDAMED

Ref ICE-422Model 25Tests/Kit EMDN W01050799

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566303438 Basic UDI-DIDate11 May 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  • Withdrawn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

Model / Reference
25Tests/Kit, ICE-422
Primary DI / UDI-DI
06974566303438
Basic UDI-DI
B-06974566303438
EMDN Code
W01050799 Multiple viruses - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019361
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhuhai Encode Medical Engineering Co., Ltd.

See all devices from Zhuhai Encode Medical Engineering Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 0082827a-b1de-4342-b895-1bf0c030573b 61 fields · synced 24 Oct 2026