Identity
- Trade Name
- Genta C-ment® EUDAMED
- Device Name
- CEMENTO ORTOPÉDICO CON ANTIBIÓTICO EUDAMED
- Model / Reference
- 1 NXT x 20g EUDAMED880265 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034467953 EUDAMED
- Basic UDI-DI
- B-07798034467953 EUDAMED
- EMDN Code
- P099001 ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Genta C-ment® by Laboratorios SL S.A. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07798034467953 | Class III | Active |
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Manufacturer
- Manufacturer
- Laboratorios SL S.A.
- EUDAMED SRN
- AR-MF-000023153
- Authorised Representative
- Synergie Ingénierie Médicale FR-AR-000001802
Sources (1)
- EUDAMED 84a69e35-6a10-4fa2-9a7f-5914cc7b2b15 61 fields · synced Jul 19, 2026