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Monkeypox Virus Antigen Rapid Test

by Avioq Bio-tech Co., Ltd. China EUDAMED

Ref 5 Tests/Kit

EMDN W0105099008

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975166204576 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Monkeypox Virus Antigen Rapid Test
Model / Reference
5 Tests/Kit
Primary DI / UDI-DI
06975166204576
Basic UDI-DI
B-06975166204576
EMDN Code
W0105099008 Monkeypox virus / mpox rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048146
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Avioq Bio-tech Co., Ltd.

See all devices from Avioq Bio-tech Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 9652e4de-4b46-4826-9244-de6b1cb58d1e 61 fields · synced 24 Oct 2026