Identity
- Trade Name
- Genta C-ment® EUDAMED
- Device Name
- CEMENTO ORTOPÉDICO CON ANTIBIÓTICO EUDAMED
- Model / Reference
- 3 NXT x 60g EUDAMED880473 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034467984 EUDAMED
- Basic UDI-DI
- B-07798034467984 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-07798034467984 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laboratorios SL S.A.
- EUDAMED SRN
- AR-MF-000023153
- Authorised Representative
- Synergie Ingénierie Médicale FR-AR-000001802
Sources (1)
- EUDAMED a928e4c1-13f2-4483-9ba7-3028063d8ff5 61 fields · synced Jun 19, 2026