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D-Dimer Turbi Latex

by Egyptian Company For Biotechnology-Spectrum Diagnostics Egypt EUDAMED

Ref 585 001 EMDN W0103020503

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-62230041019468 Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
585 001
Primary DI / UDI-DI
62230041019468
Basic UDI-DI
B-62230041019468
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

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

Other devices from Egyptian Company For Biotechnology-Spectrum Diagnostics

See all devices from Egyptian Company For Biotechnology-Spectrum Diagnostics →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED fe40cf53-fa29-4701-b82b-84599729d7bd 61 fields · synced 24 Oct 2026