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Monkeypox Virus Fluorescence PCR Kit

by Abiores Technology (Beijing) Co., Ltd. China EUDAMED

Ref ACA21D001-001DModel Cassette EMDN W0105040532

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06958982140945 Basic UDI-DIDate6 Aug 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  • Withdrawn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

Model / Reference
Cassette, ACA21D001-001D
Primary DI / UDI-DI
06958982140945
Basic UDI-DI
B-06958982140945
EMDN Code
W0105040532 Monkeypox virus / mpox - na reagent
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000022952
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Abiores Technology (Beijing) Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06958982140945|B-06958982140945 61 fields · synced 24 Oct 2026