Identity
- Trade Name
- PUREKIT GUN LV EUDAMED
- Device Name
- PUREKIT LV EUDAMED
- Model / Reference
- T060425LV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760177045330 EUDAMED
- Basic UDI-DI
- 376017704B35DB 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 low viscosity bone cement during cementoplasty procedures EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Purekit Gun Lv 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 | 376017704B35DB | Class III | Active |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-PR-000001226
Sources (1)
- EUDAMED fe4dc99c-48e9-4015-975c-75cf1b575d6a 61 fields · synced Jul 12, 2026