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PINECY® Kyphoplasty Tool Kit

by Princeton Medical Scientific Co., Ltd 15 variants

Ref FA08412, EN ISO 9626:2016, FA08402, FA20001, FA08409, FA08133, FA20002, FA08411, FA08501, FA08503, FA08603, FA08403, FA08506, FA08405, FA08132, FA08122, FA08410, FA08507, FA08502, FA08508, FA08001-02X, FA08001-02Model FA08112

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69354562PLYL08XR Basic UDI-DI Date17 Aug 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Single Use Kyphoplasty Tool Kit
Model / Reference
FA08112, FA08412, EN ISO 9626:2016, FA08402, FA20001, FA08409, FA08133, FA20002, FA08411, FA08501, FA08503, FA08603, FA08403, FA08506, FA08405, FA08132, FA08122, FA08410, FA08507, FA08502, FA08508, FA08001-02X, FA08001-02
Primary DI / UDI-DI
06935456210922, 06935456209117, 06935456209155, 06935456209124, 06935456211066, 06935456210892, 06935456210939, 06935456211073, 06935456210915, 06935456209186, 06935456210946, 06935456211028, 06935456209162, 06935456210953, 06935456210854, 06935456209131, 06935456210847, 06935456210908, 06935456210960, 06935456209209, 06935456210977, 06935456210984, 06935456209223, 06935456209094
Basic UDI-DI
69354562PLYL08XR
Direct Marketing DI
06935456210922
06935456209117
06935456209155
06935456209124
06935456211066
06935456210892
06935456210939
06935456211073
06935456210915
06935456209186
06935456210946
06935456211028
06935456209162
06935456210953
06935456210854
06935456209131
06935456210847
06935456210908
06935456210960
06935456209209
06935456210977
06935456210984
06935456209223
06935456209094
EMDN Code
N020199 Spinal catheters and kits - other
Device Class
Class IIa
EU 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

  • 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