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Newbio RPR 500

by Newmarket Biomedical Ltd United Kingdom EUDAMED

Ref NB013Model RPR

EMDN W0105010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506051514RPREF Basic UDI-DIDate23 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Newbio RPR
Model / Reference
RPR, NB013
Primary DI / UDI-DI
05060515140306, 05060515140139
Basic UDI-DI
506051514RPREF
EMDN Code
W0105010399 Syphilis reagents other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000025155
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Newmarket Biomedical Ltd

See all devices from Newmarket Biomedical Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 4fd2fa68-1bc4-4a7a-b106-374860b64239 61 fields · synced 23 Oct 2026
  • EUDAMED 05060515140139|506051514RPREF 61 fields · synced 19 May 2026