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Interface-Membrane

by Cardiawave SA EUDAMED

Active European Union

Ref CW-IM-001AModel CW-VS-002A

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770030797CW-VSYN Basic UDI-DIDate17 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2286829CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    26 Nov 2025
    Expires
    1 Nov 2030

Specification

EUDAMED

Device Name
Valvosoft®
Model / Reference
CW-VS-002A, CW-IM-001A
Primary DI / UDI-DI
03770030797016
Basic UDI-DI
3770030797CW-VSYN
EMDN Code
Z120610 Ultrasound therapy equipment
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000680

Other devices from Cardiawave SA

  • Valvosoft®

    Class IIb

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No