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INTROX® HighV - Spinal cement system
EUDAMEDFDA UDIClass III (EU MDR)
Ref SM-IN3001
by Teknimed Sas
Identity
- Trade Name
- INTROX® HighV - Spinal cement system EUDAMEDINTROX® HighV spinal cement system FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- HIGHV+ - Spinal Cement System EUDAMED
- Model / Reference
- SM-IN3001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- SM-IN3001 FDA UDI
- Primary DI / UDI-DI
- 03760177049413 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B28DE EUDAMED
- FDA Product Code
- NDN FDA UDIOAR FDA UDIJDZ FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.4200 FDA UDI888.4210 FDA UDI
- Medical Purpose
- The system is intended to mix and inject high viscosity bone cement during cementoplasty procedures EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
INTROX® HighV - Spinal cement system by Teknimed Sas — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376017704B28DE | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-PR-000001226
Sources (2)
- EUDAMED 2ac0894d-a6ab-4d71-8772-ee3c99b4053b 61 fields · synced Jul 17, 2026
- FDA UDI 41beeaa8-7163-4dcf-a6ef-f606d341743f 34 fields · synced May 30, 2026