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Hydrus

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

Ref 02Model PB-040-080-090

EMDN C01050299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970757205017 Basic UDI-DIDate24 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 24 Oct 2026

Device Name
Balloon Dilatation Catheter
Model / Reference
PB-040-080-090, 02
Primary DI / UDI-DI
06970757205017
Basic UDI-DI
B-06970757205017
EMDN Code
C01050299 Intravascular embolic protection catheters and systems - other
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

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

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 c62a873f-41a5-4453-806d-94a7283d6f16 61 fields · synced 24 Oct 2026