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Syringes 1.5cc
EUDAMEDFDA UDIClass I (EU MDR)
Ref T060428Model Mixing and injection system for bone cement
by Teknimed Sas
Identity
- Trade Name
- Syringes 1.5cc EUDAMEDFDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- PUREKIT EUDAMED
- Model / Reference
- Mixing and injection system for bone cement EUDAMEDT060428 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701505801099 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B33D7 EUDAMED
- FDA Product Code
- OAR 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 I EUDAMEDFDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Syringes 1.5cc by Teknimed Sas — Class I — 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 | 376017704B33D7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-MF-000001224
Sources (2)
- EUDAMED 4311f950-a5e1-4eb6-ad05-b409eb80f6d7 61 fields · synced Jun 19, 2026
- FDA UDI b50fc185-3864-40a5-98d1-a76039e83eb8 32 fields · synced May 30, 2026