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EUDAMEDClass III (EU MDR)
Ref 884411Ref 884413Ref 884415Ref 884409Ref 884417Ref 884400Ref 884405Ref 884401
Identity
- Trade Name
- Link EUDAMED
- Device Name
- Link Knee Spacer with gentamicin EUDAMEDLink Hip Spacer with gentamicin EUDAMED
- Model / Reference
- 884411 EUDAMED884413 EUDAMED884415 EUDAMED884409 EUDAMED884417 EUDAMED884400 EUDAMED884405 EUDAMED884401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700448214898 EUDAMED03700448214911 EUDAMED03700448214935 EUDAMED03700448214874 EUDAMED03700448214959 EUDAMED03700448214782 EUDAMED03700448214836 EUDAMED03700448214799 EUDAMED
- Basic UDI-DI
- B-03700448214898 EUDAMEDB-03700448214911 EUDAMEDB-03700448214935 EUDAMEDB-03700448214874 EUDAMEDB-03700448214959 EUDAMEDB-03700448214782 EUDAMEDB-03700448214836 EUDAMEDB-03700448214799 EUDAMED
- EMDN Code
- P090908 KNEE PROSTHESES SPACERS EUDAMEDP090805 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
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
Link 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-03700448214898 | Class III | Active |
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Manufacturer
- Manufacturer
- Synergie Ingenierie Medicale
- EUDAMED SRN
- FR-MF-000001635
Sources (8)
- EUDAMED a1ae0fae-605c-405f-9be8-0c11952c9944 61 fields · synced Oct 7, 2026
- EUDAMED 1f037c56-79af-4cc8-b986-d5d0aa8db87d 61 fields · synced May 16, 2026
- EUDAMED 8d8d67dc-972a-4596-8000-4a688ed7824d 61 fields · synced May 17, 2026
- EUDAMED 9ffb7d40-63d0-4aae-8e12-138c45b8e5ba 61 fields · synced May 17, 2026
- EUDAMED 58c96122-8171-46a2-b519-95860c2749ae 61 fields · synced May 17, 2026
- EUDAMED 86f55f02-22e3-4618-ba07-9963f3e00c03 61 fields · synced May 17, 2026
- EUDAMED f4e97380-a78f-4a9a-8af2-b56c5bc6e285 61 fields · synced May 17, 2026
- EUDAMED c7563ad4-53d1-4328-b7eb-62a7af87e9f6 61 fields · synced May 18, 2026