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Humivent

by Engin Medikal Tıbbi Malzeme San Ve Tic Ltd Şti. Türkiye EUDAMED

Ref 3530Model Humivent

EMDN R040201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number086851112883VENTVN Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Heat and Moisture Exchanger
Model / Reference
Humivent, 3530
Primary DI / UDI-DI
08685111288305
Basic UDI-DI
086851112883VENTVN
Direct Marketing DI
08685111288305
EMDN Code
R040201 Tracheostomy humidifiers
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000050089

Other devices from Engin Medikal Tıbbi Malzeme San Ve Tic Ltd Şti.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 6d2c0dee-f770-4fd6-b2c9-06519f032c66 61 fields · synced 24 Oct 2026