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Vesscrack

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

Ref 3.75×12

EMDN C010401020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69367337LP0042MN Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 818410 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    20 Jan 2026
    Expires
    19 Jan 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Coronary IVL Balloon Dilatation Catheter
Model / Reference
3.75×12
Primary DI / UDI-DI
06941785262211
Basic UDI-DI
69367337LP0042MN
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
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

Sources (1)

  • EUDAMED 06941785262211|69367337LP0042MN 61 fields · synced 24 Oct 2026