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Mycoplasma Pneumoniae Antigen Rapid Test

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

Active European Union

Ref GS110122C25Model 25 tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977903344620 Basic UDI-DIDate12 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  • Withdrawn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

Device Name
Mycoplasma Pneumoniae Antigen Rapid Test
Model / Reference
25 tests/kit, GS110122C25
Primary DI / UDI-DI
06977903344620
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000044463
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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