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Kyphoplasty Tool Kit

by Jiangsu Changmei Medtech Co., Ltd. China EUDAMED

Ref KT-00-11Model KT-00-01 EMDN P099002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69235585KT07CE01U7 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

NorwayNorwayIcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

EU market availability

Available in 32 countries, as listed in EUDAMED:

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Last checked 24 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Kyphoplasty Tool Kit
Model / Reference
KT-00-01, KT-00-11
Primary DI / UDI-DI
06923558502823
Basic UDI-DI
69235585KT07CE01U7
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012609
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Changmei Medtech Co., Ltd.

See all devices from Jiangsu Changmei Medtech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 06923558502823|69235585KT07CE01U7 61 fields · synced 24 Oct 2026