Skip to content

Monkeypox Virus Antigen Rapid Test

by GeneSign Biotech (Xiamen)Co., Ltd. China EUDAMED

Ref GS110222C25

EMDN W0105099008

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977903342923 Basic UDI-DIDate9 Jun 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 22 Oct 2026

Device Name
Monkeypox Virus Antigen Rapid Test
Model / Reference
GS110222C25
Primary DI / UDI-DI
06977903342923
Basic UDI-DI
B-06977903342923
EMDN Code
W0105099008 Monkeypox virus / mpox rt & poc
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000044463
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from GeneSign Biotech (Xiamen)Co., Ltd.

See all devices from GeneSign Biotech (Xiamen)Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 15c02999-5021-449d-bc3b-cb65879f1e53 61 fields · synced 22 Oct 2026