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Rotavirus Antigen Rapid Test

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

Ref GS110504C01Model 1 test/kit EMDN W0105040606

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977903342114 Basic UDI-DIDate11 Jun 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  • Withdrawn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 22 Oct 2026

Device Name
Rotavirus Antigen Rapid Test
Model / Reference
1 test/kit, GS110504C01
Primary DI / UDI-DI
06977903342114
Basic UDI-DI
B-06977903342114
EMDN Code
W0105040606 Rotavirus
Device Class
Class IVD General
Market of Registration
Netherlands

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 c61c74eb-9707-4f76-b422-00d10b1d18e7 61 fields · synced 22 Oct 2026