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Mini-Malax adapted to High Viscosity Injection System
EUDAMEDFDA UDIClass I (EU MDR)
Ref T060420Model Mixing and injection system for bone cement
by Teknimed Sas
Identity
- Trade Name
- Mini-Malax adapted to High Viscosity Injection System EUDAMEDMixing System Adapted to High Viscosity Injection System FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Mini-Malax EUDAMED
- Model / Reference
- Mixing and injection system for bone cement EUDAMEDT060420 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- T060420 FDA UDI
- Primary DI / UDI-DI
- 03760177043138 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B23D4 EUDAMED
- FDA Product Code
- JDZ 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
- 888.4210 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
Mini-Malax adapted to High Viscosity Injection System 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 | 376017704B23D4 | 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 6c227b9c-757b-41db-be1a-527242744bd5 61 fields · synced Jun 18, 2026
- FDA UDI 804d2a09-4487-498e-8baf-4f39b7b75c3b 33 fields · synced May 30, 2026