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Monkeypox Virus Ag Test

by Abiores Technology (Beijing) Co., Ltd.

Ref AB331-20Model Strip & Cassette

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06958982140402 Basic UDI-DI 06958982140402UDI-DIDate28 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
Strip & Cassette, AB331-20
Primary DI / UDI-DI
06958982140402
Basic UDI-DI
B-06958982140402
EMDN Code
W0105099008 Monkeypox virus / mpox rt & poc
Device Class
Class IVD General
EU market of registration
Croatia

Manufacturer details

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

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Properties

  • Sterile
  • Reagent
  • Self Testing
  • Professional Testing

Other properties (6)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No