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Factor VIII Deficient Plasma

by Wiener Laboratorios SAIC Argentina EUDAMED

Ref 1705017 EMDN W0103020207

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07798100048802 Basic UDI-DIDate1 Jul 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
1705017
Primary DI / UDI-DI
07798100048802
Basic UDI-DI
B-07798100048802
EMDN Code
W0103020207 Coagulation factor viii
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
AR-MF-000023605
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties & raw data

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

Sources (1)

  • EUDAMED 07798100048802|B-07798100048802 61 fields · synced 25 Oct 2026