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Vesscide

by Lepu Medical Technology (Beijing) Co., Ltd. China EUDAMED

Ref 3.5 × 5

EMDN C010401020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69367337LP0046MW Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 818411 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    8 Apr 2026
    Expires
    3 Aug 2030
    Reason
    Other

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Cutting Balloon Dilatation Catheter
Model / Reference
3.5 × 5
Primary DI / UDI-DI
06941785257187
Basic UDI-DI
69367337LP0046MW
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000001408
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Lepu Medical Technology (Beijing) Co., Ltd.

See all devices from Lepu Medical Technology (Beijing) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
Other properties (11)
  • Implantable: No
  • 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

Sources (1)

  • EUDAMED 06941785257187|69367337LP0046MW 61 fields · synced 25 Oct 2026