Skip to content

Epstein-Barr virus Detection Kit (Fluorescence PCR)

by Hangzhou Danwei Biotechnology Co., Ltd China EUDAMED

Ref 101A0204EY EMDN W0105040403

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697603130A0204EYRS4J Basic UDI-DIDate19 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  • Withdrawn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

Device Name
Epstein-Barr virus Detection Kit (Fluorescence PCR)
Model / Reference
101A0204EY
Primary DI / UDI-DI
D-697603130A0204EYRS4J
Basic UDI-DI
B-697603130A0204EYRS4J
EMDN Code
W0105040403 Ebv - 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
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-697603130A0204EYRS4J|B-697603130A0204EYRS4J 61 fields · synced 24 Oct 2026