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HV 1300 - Spinal cement system
EUDAMEDClass III (EU MDR)
Ref T040326K
by Teknimed Sas
Identity
- Trade Name
- HV 1300 - Spinal cement system EUDAMED
- Device Name
- HIGHV+ - Spinal Cement System EUDAMED
- Model / Reference
- T040326K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701505801198 EUDAMED
- Basic UDI-DI
- 376017704B28DE EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The system is intended to mix and inject high viscosity bone cement during cementoplasty procedures EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
HV 1300 - Spinal cement system by Teknimed Sas — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376017704B28DE | Class III | Active |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-PR-000001226
Sources (1)
- EUDAMED 9eb233c4-57b1-40c8-9598-8725e012989c 61 fields · synced Jul 14, 2026