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Mini-Malax adapted to S5 Injector
EUDAMEDClass I (EU MDR)
Ref T060419Model Mixing and injection system for bone cement
by Teknimed Sas
Identity
- Trade Name
- Mini-Malax adapted to S5 Injector EUDAMED
- Device Name
- Mini-Malax EUDAMED
- Model / Reference
- Mixing and injection system for bone cement EUDAMEDT060419 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760177043121 EUDAMED
- Basic UDI-DI
- 376017704B23D4 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Mini-Malax adapted to S5 Injector by Teknimed Sas — Class I — 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 | 376017704B23D4 | Class I | Active |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-MF-000001224
Sources (1)
- EUDAMED 1e8956d8-0bcc-4568-ab81-3fc40fe5b61d 61 fields · synced Jul 9, 2026