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Monkeypox Virus Detection Kit (Fluorescence PCR)

by Hangzhou Danwei Biotechnology Co., Ltd China EUDAMED

Ref AMPV01，AMPV01D EMDN W0105040532

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697603130AMPV01EMWG 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  • Withdrawn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 24 Oct 2026

Device Name
Monkeypox Virus Detection Kit (Fluorescence PCR)
Model / Reference
AMPV01，AMPV01D
Primary DI / UDI-DI
D-697603130AMPV01EMWG
Basic UDI-DI
B-697603130AMPV01EMWG
EMDN Code
W0105040532 Monkeypox virus / mpox - na reagent
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 04927d76-03c4-4c79-b13e-3eb8db58f908 61 fields · synced 24 Oct 2026