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SARS-CoV-2 & Influenza A/B & Respiratory Syncytial Virus & Adeno Virus Antigen Combo Test Kit

by Sejoy Biomedical Co., Ltd. 3 variants

Ref ISIRA-9445

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06939663978484 Basic UDI-DI 06939663978484UDI-DIDate25 Jun 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  • Withdrawn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

Device Name
SARS-CoV-2 & Influenza A/B & Respiratory Syncytial Virus & Adeno Virus Antigen Combo Test Kit
Model / Reference
ISIRA-9445
Primary DI / UDI-DI
06939663978484
Basic UDI-DI
B-06939663978484
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
Device Class
Class IVD General
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008447
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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