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Simple AG SARS-CoV-2 / Flu A+B

by Operon, S.A.

Ref 9.242.020.36.000

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-84295779242Y3GZ Basic UDI-DI D-84295779242Y3GZUDI-DIDate24 Sep 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  • Withdrawn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
9.242.XXX.YY.ZZZ
Model / Reference
9.242.020.36.000
Primary DI / UDI-DI
D-84295779242Y3GZ
Basic UDI-DI
B-84295779242Y3GZ
EMDN Code
W0105090601 Coronavirus / influenza - rt & poc
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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