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SARS-CoV-2 Detection Kit (Fluorescence RT-PCR)

by Hangzhou Danwei Biotechnology Co., Ltd China EUDAMED

Ref ACOV03,ACOV03D EMDN W0105070304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-W0105070304EM Basic UDI-DIDate25 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  • Withdrawn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 25 Oct 2026

Device Name
SARS-CoV-2 Detection Kit (Fluorescence RT-PCR)
Model / Reference
ACOV03, ACOV03D
Primary DI / UDI-DI
D-W0105070304EM
Basic UDI-DI
B-W0105070304EM
EMDN Code
W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000041344
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hangzhou Danwei Biotechnology Co., Ltd

See all devices from Hangzhou Danwei Biotechnology Co., Ltd →

Properties & raw data

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

Sources (1)

  • EUDAMED D-W0105070304EM|B-W0105070304EM 61 fields · synced 25 Oct 2026