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SkyLoach

by Skynor Medical（Shanghai）Co., Ltd China EUDAMED

Ref 07Model IB-2020

EMDN C019010

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970757200104 Basic UDI-DIDate3 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Intracranial Balloon Dilatation Catheter
Model / Reference
IB-2020, 07
Primary DI / UDI-DI
06970757200104
Basic UDI-DI
B-06970757200104
EMDN Code
C019010 Intravascular recanalisation systems
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000028227
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Related devices

Category: Vascular graft tunneller

Other devices from Skynor Medical（Shanghai）Co., Ltd

See all devices from Skynor Medical（Shanghai）Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c664a9e5-6a03-417d-b74b-5e9f05c0819a 61 fields · synced 22 Oct 2026