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PINECY® Kyphoplasty Tool Kit

by Princeton Medical Scientific Co., Ltd China EUDAMED

Ref FA08408Model FA08112

EMDN N020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69354562PLYL08XR Basic UDI-DIDate17 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Sterile Single Use Kyphoplasty Tool Kit
Model / Reference
FA08112, FA08408
Primary DI / UDI-DI
06935456210885
Basic UDI-DI
69354562PLYL08XR
Direct Marketing DI
06935456210885
EMDN Code
N020199 Spinal catheters and kits - other
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

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

Other devices from Princeton Medical Scientific Co., Ltd

See all devices from Princeton Medical Scientific Co., 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 9e6a2283-668e-438c-b7ec-7fff04e37ecb 61 fields · synced 23 Oct 2026