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FortCem
EUDAMEDClass III (EU MDR)
Ref 881317Ref 881304Ref 881325Ref 881321Ref 881305Ref 881307Ref 881311Ref 881322Ref 881315Ref 881306
Identity
- Trade Name
- FortCem EUDAMED
- Device Name
- FortCem Knee Spacer with gentamicin EUDAMEDFortCem Hip Spacer with Gentamicin EUDAMEDFortCem Shoulder Spacer with gentamicin EUDAMED
- Model / Reference
- 881317 EUDAMED881304 EUDAMED881325 EUDAMED881321 EUDAMED881305 EUDAMED881307 EUDAMED881311 EUDAMED881322 EUDAMED881315 EUDAMED881306 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700448209887 EUDAMED03700448209757 EUDAMED03700448216083 EUDAMED03700448209924 EUDAMED03700448209764 EUDAMED03700448209788 EUDAMED03700448209825 EUDAMED03700448209931 EUDAMED03700448209863 EUDAMED03700448209771 EUDAMED
- Basic UDI-DI
- B-03700448209887 EUDAMEDB-03700448209757 EUDAMEDB-03700448216083 EUDAMEDB-03700448209924 EUDAMEDB-03700448209764 EUDAMEDB-03700448209788 EUDAMEDB-03700448209825 EUDAMEDB-03700448209931 EUDAMEDB-03700448209863 EUDAMEDB-03700448209771 EUDAMED
- EMDN Code
- P090908 KNEE PROSTHESES SPACERS EUDAMEDP090805 HIP PROSTHESES SPACERS EUDAMEDP090199 SHOULDER PROSTHESES - OTHER EUDAMEDP09098001 KNEE PROSTHESES AUGMENTS 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
FortCem 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-03700448209887 | Class III | Active |
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Manufacturer
- Manufacturer
- Synergie Ingenierie Medicale
- EUDAMED SRN
- FR-MF-000001635
Sources (10)
- EUDAMED 66b0a2ca-095d-4c34-81d5-7f6c9e221792 61 fields · synced Oct 7, 2026
- EUDAMED b2ff6274-312d-476e-bbe9-b4c51789908a 61 fields · synced May 16, 2026
- EUDAMED 0010b892-3bc6-48a3-b1ae-db403435fe47 61 fields · synced May 16, 2026
- EUDAMED e8500bf6-8e19-470a-896e-c55c82de7ec3 61 fields · synced May 17, 2026
- EUDAMED f61cbeef-d891-4417-ad23-c995d9f78e8d 61 fields · synced May 17, 2026
- EUDAMED f879759c-12ee-42c1-b870-3a17f815186a 61 fields · synced May 17, 2026
- EUDAMED 65658fec-d78f-4ae7-afe9-27b95b72c3ea 61 fields · synced May 17, 2026
- EUDAMED 7bd0e2e8-33a0-4e1f-b5e4-730141a0bbef 61 fields · synced May 18, 2026
- EUDAMED 608d137a-afbd-42df-948c-197c4ca14773 61 fields · synced May 18, 2026
- EUDAMED b8de8d72-9119-44eb-ae67-cf0b4183445b 61 fields · synced May 19, 2026