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Balloon Inflation Device

by SCW Medicath Ltd. China EUDAMED

Ref 42.04.60002 EMDN C0104010280

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69388205000000000000002ZN Basic UDI-DIDate14 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
42.04.60002
Primary DI / UDI-DI
06938820571919
Basic UDI-DI
69388205000000000000002ZN
EMDN Code
C0104010280 Interventional coronary angiography devices - accessories
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000019140
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from SCW Medicath Ltd.

See all devices from SCW Medicath 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 06938820571919|69388205000000000000002ZN 61 fields · synced 25 Oct 2026