Skip to content

Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)

by Shanghai GeneoDx Biotech Co., Ltd. China EUDAMED

Ref GZ-MPV024 EMDN W0105040599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974593880117 Basic UDI-DIDate14 Nov 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  • Withdrawn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

Model / Reference
GZ-MPV024
Primary DI / UDI-DI
06974593880117
Basic UDI-DI
B-06974593880117
EMDN Code
W0105040599 Virology - na reagents - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000029299
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai GeneoDx Biotech 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 262f170b-f9e1-4c96-bd45-3bfe1b7e6e53 61 fields · synced 22 Oct 2026