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RPR Syphilis Test

by Egyptian Company For Biotechnology-Spectrum Diagnostics EUDAMED 3 variants

Active European Union

Ref 725 000

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-62230041032924 Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
725 000
Primary DI / UDI-DI
62230041032924
Basic UDI-DI
B-62230041032924
EMDN Code
W0105010302 Syphilis antibody assays total
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
EG-MF-000032599
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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