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RPR Carbon Antigen

by Lorne Laboratories Ltd United Kingdom EUDAMED

Ref 045005AModel Rapid Agglutination Syphilis Kits

EMDN W0105010301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060168051264 Basic UDI-DIDate6 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
RPR Carbon Antigen 100 Tests Kit
Model / Reference
Rapid Agglutination Syphilis Kits, 045005A
Primary DI / UDI-DI
05060168051264
Basic UDI-DI
B-05060168051264
EMDN Code
W0105010301 Syphilis antigen detection
Device Class
Class IVD General
Market of Registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000029354
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Lorne Laboratories Ltd

See all devices from Lorne Laboratories Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 05060168051264|B-05060168051264 61 fields · synced 24 Oct 2026