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Dragonfly™ Transcatheter Mitral Valve Repair System

by Hangzhou Valgen Medtech Co., Ltd 5 variants

Ref GS24800

Active European Union

CE MDR

Valid until

1 Apr 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69715077500018T Basic UDI-DI 06971507751174UDI-DIDate21 Jul 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2283633CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    7 Apr 2025
    Expires
    1 Apr 2030
  • 2283633TD01 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    7 Apr 2025
    Expires
    1 Apr 2030

Coverage

1 jurisdiction

PolandHungarySpainTürkiye
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

  • Hungary
  • Poland
  • Spain
  • Türkiye

Specification

EUDAMED

Model / Reference
GS24800
Primary DI / UDI-DI
06971507751174
Basic UDI-DI
69715077500018T
EMDN Code
P07038004 Heart valve reconstruction implants
Device Class
Class III
EU 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

See all devices from Hangzhou Valgen Medtech Co., Ltd →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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