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Deben Shigella Antisera

by Deben Diagnostics Ltd 52 variants

Ref 295019Model flexneri type II

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-05061053153049 Basic UDI-DI 05061053153049UDI-DIDate13 Aug 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  • Withdrawn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
Deben Shigella Antisera
Model / Reference
flexneri type II, 295019
Primary DI / UDI-DI
05061053153049
Basic UDI-DI
B-05061053153049
EMDN Code
W01029001 Antisera (monovalent and polyvalent)
Device Class
Class IVD General
EU market of registration
Luxembourg

Manufacturer details

EUDAMED SRN
GB-MF-000023695
Authorised representative
EU-UK Authorised Representative Ltd XI-AR-000010192

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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