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Intensive Care Ventilator Zisline MV350

by Triton Electronic Systems Ltd EUDAMED

Withdrawn Not intended for the EU market

Ref MV350

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number464010290RES001WC Basic UDI-DIDate19 Jun 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Intensive Care Ventilator Zisline MV200, MV300, MV350
Model / Reference
MV350
Primary DI / UDI-DI
04640102900677
Basic UDI-DI
464010290RES001WC
Direct Marketing DI
04640102900677
EMDN Code
Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
RU-MF-000015915
Authorised representative
Wladimir Wollert DE-AR-000012926

Properties

Show properties
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No