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ISE Reagent Module

by Wiener Laboratorios SAIC Argentina EUDAMED

Ref 1572570

EMDN W0101050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7798100041572570KY Basic UDI-DIDate17 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
1572570
Primary DI / UDI-DI
07791778045074
Basic UDI-DI
7798100041572570KY
EMDN Code
W0101050301 Calibrators multicomponent (cc)
Device Class
Class A

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 & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 20916407-0655-42ac-8daf-841a3971a2f3 61 fields · synced 24 Oct 2026