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Dragonfly™ Transcatheter Mitral Valve Repair System

by Hangzhou Valgen Medtech Co., Ltd EUDAMED

Active European Union

Ref XW0612

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69715077500018T Basic UDI-DIDate21 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2283633CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    7 Apr 2025
    Expires
    1 Apr 2030
  • 2283633TD01 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    7 Apr 2025
    Expires
    1 Apr 2030

Specification

EUDAMED

Model / Reference
XW0612
Primary DI / UDI-DI
06971507751211
Basic UDI-DI
69715077500018T
EMDN Code
P07038004 Heart valve reconstruction implants
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000037140
Authorised representative
MedNet EC-REP C III GmbH DE-AR-000011196

Other devices from Hangzhou Valgen Medtech Co., Ltd

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Properties

Show properties
  • Sterile
  • Implantable
  • CMR Substance
Other properties (10)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No