← Back to catalogue
PureKit Syringes 4cc/MV
EUDAMEDFDA UDIClass III (EU MDR)
Ref T060426MV
by Teknimed Sas
Identity
- Trade Name
- PureKit Syringes 4cc/MV EUDAMEDPureKit Syringe 4cc MV FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- PUREKIT MV EUDAMED
- Model / Reference
- T060426MV EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701505800498 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B34D9 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 medium 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
PureKit Syringes 4cc/MV 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 | 376017704B34D9 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-PR-000001226
Sources (2)
- EUDAMED 3cf8236d-d082-4cc4-a560-3e736ea97f7a 61 fields · synced Jul 10, 2026
- FDA UDI 90c0b0cc-dcfd-485a-982b-4489a7b82c37 32 fields · synced May 30, 2026