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Espaciador de Rodilla LINK
EUDAMEDClass III (EU MDR)
Ref 881542Model Simétrico y Asimétrico
Identity
- Trade Name
- Espaciador de Rodilla LINK EUDAMED
- Device Name
- Espaciador de rodilla con gentamicina EUDAMED
- Model / Reference
- Simétrico y Asimétrico EUDAMED881542 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034465478 EUDAMED
- Basic UDI-DI
- 779803446Spacers-GZA EUDAMED
- EMDN Code
- P090908 KNEE PROSTHESES SPACERS 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
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
Yes
EUDAMED
Espaciador de Rodilla LINK by Laboratorios SL S.A. — Class III — 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 | 779803446Spacers-GZA | 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 816ea48d-9f4b-4e22-bcce-aae9081398cc 61 fields · synced Jul 27, 2026