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Espaciador de cadera SUBITON
EUDAMEDClass III (EU MDR)
Ref 880928Model Charnley y Müller
Identity
- Trade Name
- Espaciador de cadera SUBITON EUDAMED
- Device Name
- Espaciador de cadera con gentamicina EUDAMED
- Model / Reference
- Charnley y Müller EUDAMED880928 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034469285 EUDAMED
- Basic UDI-DI
- 779803446SpacersHipJM EUDAMED
- EMDN Code
- P090805 HIP 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 cadera SUBITON 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 | 779803446SpacersHipJM | 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 6cdaf2c6-8f73-4d1c-9b9a-a9272ef6fec9 61 fields · synced Jul 19, 2026