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Monkeypox Virus Nucleic Acid Kit (Fluorescent PCR)

by Henan Vacure Biotechnology Co., Ltd. China EUDAMED

Ref / EMDN W0105040599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-TD-HNVC-CED-08XG Basic UDI-DIDate25 May 2022RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Monkeypox Virus Nucleic Acid Kit (Fluorescent PCR)
Model / Reference
/
Primary DI / UDI-DI
D-TD-HNVC-CED-08XG
Basic UDI-DI
B-TD-HNVC-CED-08XG
EMDN Code
W0105040599 Virology - na reagents - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000023292
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Henan Vacure Biotechnology Co., Ltd.

See all devices from Henan Vacure Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 52578c68-1102-4921-b9f4-bbb632c5462e 61 fields · synced 22 Oct 2026