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SARS-CoV-2 AntigenTest kit (LFIA)

by Jiangsu Medomics Medical Technology Co., Ltd. 2 variants

Ref 1031-54-01

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-06974167890078 Basic UDI-DI 06974167890078UDI-DIDate9 Oct 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  • Withdrawn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

Device Name
SARS-CoV-2 AntigenTest kit (LFIA)
Model / Reference
1031-54-01
Primary DI / UDI-DI
06974167890078
Basic UDI-DI
B-06974167890078
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD devices for self-testing
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000030226
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Jiangsu Medomics Medical Technology Co., Ltd.

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Properties

  • Microbial Substances
  • Reagent
  • Self Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No