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Hydrus

by Skynor Medical（Shanghai）Co., Ltd EUDAMED

Active European Union

Ref 02Model PB-030-200-090

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970757204836 Basic UDI-DIDate23 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Balloon Dilatation Catheter
Model / Reference
PB-030-200-090, 02
Primary DI / UDI-DI
06970757204836
Basic UDI-DI
B-06970757204836
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

  • 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