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Kyphotray Working Cannula and Diamond Tip

by Biopsybell SRL EUDAMED

Active European Union

Ref KTY08-WD

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033860KYPFT05A9T Basic UDI-DIDate20 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • IT353495 Amended

    Quality management system EU MDR

    Notified body
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    4 Sep 2026
    Expires
    14 Jun 2031
    Reason
    Other
  • IT349638 Withdrawn

    Quality assurance EU MDR

    Notified body
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    10 Feb 2026
    Expires
    9 Feb 2030
    Reason
    Other

Specification

EUDAMED

Device Name
Kyphoplasty Systems
Model / Reference
KTY08-WD
Primary DI / UDI-DI
08033860052515
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000011601

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