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Breathing Circuit & Accessories (Bain Circuit, Ventilator Circuit, HME Filter)

by Poly Medicure Limited EUDAMED

Active European Union

Ref 20425Model Ventilator Circuit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890209520415EA Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Ventilator Circuit, 20425
Primary DI / UDI-DI
08902095204252
Basic UDI-DI
890209520415EA
EMDN Code
R028099 Respiratory circuits and mount catheters - accessories not included in other classes
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000043009
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Show properties
  • Sterile
Other properties (12)
  • 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