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Deben Latex Agglutination Reagin

by Deben Diagnostics Ltd 6 variants

Ref 80008Model C-reactive Protein (CRP)

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-05061053154206 Basic UDI-DI 05061053154206UDI-DIDate13 Oct 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  • Withdrawn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 Latex Agglutination Reagin
Model / Reference
C-reactive Protein (CRP), 80008
Primary DI / UDI-DI
05061053154206
Basic UDI-DI
B-05061053154206
EMDN Code
W01021109 C-reactive protein
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

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

Other devices from Deben Diagnostics Ltd

See all devices from Deben Diagnostics Ltd →

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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