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Prothrombin Time

by Wiener Laboratorios SAIC EUDAMED

Active European Union

Ref 42001

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07798100040035 Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Soluplastin
Model / Reference
42001
Primary DI / UDI-DI
07798100040035
Basic UDI-DI
B-07798100040035
EMDN Code
W0103020101 Prothrombin time ( quick test )
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

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

Other devices from Wiener Laboratorios SAIC

See all devices from Wiener Laboratorios SAIC →

Properties

  • 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