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Eurofix
EUDAMEDClass III (EU MDR)
Ref 884174Ref 884123Ref 884124Ref 881225Ref 884171Ref 884173Ref 884128Ref 884127Ref 884175Ref 884129Ref 884172
Identity
- Trade Name
- Eurofix EUDAMED
- Device Name
- Eurofix Knee Spacer with gentamicin EUDAMEDEurofix Hip Spacer with Gentamicin EUDAMEDEurofix Shoulder Spacer with gentamicin EUDAMED
- Model / Reference
- 884174 EUDAMED884123 EUDAMED884124 EUDAMED881225 EUDAMED884171 EUDAMED884173 EUDAMED884128 EUDAMED884127 EUDAMED884175 EUDAMED884129 EUDAMED884172 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700448208101 EUDAMED03700448208316 EUDAMED03700448208323 EUDAMED03700448208972 EUDAMED03700448208071 EUDAMED03700448208095 EUDAMED03700448201775 EUDAMED03700448201768 EUDAMED03700448208118 EUDAMED03700448201782 EUDAMED03700448208088 EUDAMED
- Basic UDI-DI
- B-03700448208101 EUDAMEDB-03700448208316 EUDAMEDB-03700448208323 EUDAMEDB-03700448208972 EUDAMEDB-03700448208071 EUDAMEDB-03700448208095 EUDAMEDB-03700448201775 EUDAMEDB-03700448201768 EUDAMEDB-03700448208118 EUDAMEDB-03700448201782 EUDAMEDB-03700448208088 EUDAMED
- EMDN Code
- P090908 KNEE PROSTHESES SPACERS EUDAMEDP090805 HIP PROSTHESES SPACERS EUDAMEDP090199 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Eurofix by Synergie Ingenierie Medicale — 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-03700448208101 | Class III | Active |
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Manufacturer
- Manufacturer
- Synergie Ingenierie Medicale
- EUDAMED SRN
- FR-MF-000001635
Sources (11)
- EUDAMED 0e194e9b-3523-4919-85c9-81a542775f22 61 fields · synced Oct 8, 2026
- EUDAMED b55c7950-ff05-4d1c-820f-d92fa6f32b91 61 fields · synced May 11, 2026
- EUDAMED 3f04fb21-355d-4dd0-a7de-0454141ed3b8 61 fields · synced May 16, 2026
- EUDAMED 9c33ecb4-c0af-4aad-94d5-9ae277cb6258 61 fields · synced May 17, 2026
- EUDAMED 695804a9-1915-4b4e-9b26-62dcca2f02e2 61 fields · synced May 17, 2026
- EUDAMED e24a6e2b-284d-423d-9d0b-ce2aac76b7a4 61 fields · synced May 17, 2026
- EUDAMED c72fc7cb-314c-4998-ad46-c19536e3e78d 61 fields · synced May 17, 2026
- EUDAMED 39107264-1d6e-4c84-8ea6-00952d38082c 61 fields · synced May 18, 2026
- EUDAMED 89c33c20-53b6-4fbb-aea9-a74a23c95666 61 fields · synced May 18, 2026
- EUDAMED e7fa5ae6-e239-4e24-bcf9-5c0642cba433 61 fields · synced May 18, 2026
- EUDAMED 549e2a61-a3da-4e95-b7a7-8c06f044c726 61 fields · synced May 18, 2026