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COVID-19 & Influenza A/B Antigen Combo Test Kit

by Shenzhen Reagent Technology Co., Ltd.

Ref RNS92048C

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974443200034 Basic UDI-DI 06974443200034UDI-DIDate9 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
RNS92048C
Primary DI / UDI-DI
06974443200034
Basic UDI-DI
B-06974443200034
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
Device Class
Class IVD General
EU market of registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000047757
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No