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Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)

by Shanghai GeneoDx Biotech Co., Ltd. EUDAMED

Active European Union

Ref GZ-MPV100

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974593880124 Basic UDI-DIDate15 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  • Withdrawn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

Model / Reference
GZ-MPV100
Primary DI / UDI-DI
06974593880124
Basic UDI-DI
B-06974593880124
EMDN Code
W01050499 Virology 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

Show properties
  • 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