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Deben Treponema Pallidum Reagin

by Deben Diagnostics Ltd 6 variants

Ref 90004Model Rapid Plasma Reagin (RPR) Kit

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05061053154275 Basic UDI-DI 05061053154275UDI-DIDate13 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
Deben Treponema Pallidum Reagin
Model / Reference
Rapid Plasma Reagin (RPR) Kit, 90004
Primary DI / UDI-DI
05061053154275
Basic UDI-DI
B-05061053154275
EMDN Code
W0105010306 Syphilis, reagin antibodies
Device Class
Class IVD General

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