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PINECY® Kyphoplasty Balloon Catheter

by Princeton Medical Scientific Co., Ltd EUDAMED

Active European Union

Ref FA03001-05

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69354562PLYL03XF Basic UDI-DIDate7 Nov 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
FA03001-05
Primary DI / UDI-DI
06935456210342
Direct Marketing DI
06935456210342
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000018402
Authorised representative
Wellkang Ltd XI-AR-000001836

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