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X'tens Kypho

by Thiebaud France EUDAMED

Ref XTST35R-2Model Bone cement injector

EMDN A01020203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37014412CEM015J Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
X'tens range
Model / Reference
Bone cement injector, XTST35R-2
Primary DI / UDI-DI
03701441208990
Basic UDI-DI
37014412CEM015J
Direct Marketing DI
03701441208990
EMDN Code
A01020203 Vertebral and paravertebral biopsy needles and kits
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000016223

Other devices from Thiebaud

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 3d008921-79e5-43b9-8763-84737b3ec505 61 fields · synced 22 Oct 2026