Identity
- Trade Name
- LINK Spacer Shoulder EUDAMED
- Device Name
- Espaciador de Hombro con Gentamicina EUDAMED
- Model / Reference
- HA40 - HA48 EUDAMED884442 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034468110 EUDAMED
- Basic UDI-DI
- 779803446SpacerShoulderFM EUDAMED
- EMDN Code
- P090199 SHOULDER PROSTHESES - OTHER 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
LINK Spacer Shoulder 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 | 779803446SpacerShoulderFM | 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 ae591a54-f02c-4645-b7f9-6faf776692a7 61 fields · synced Jul 23, 2026