Identity
- Trade Name
- DIAM, Bi-Lateral Impactor EUDAMED
- Device Name
- Bi-Lateral Impactor EUDAMED
- Model / Reference
- CS001B0025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701521300019 EUDAMED
- Basic UDI-DI
- 37015213FDMN00054Z EUDAMED
- Direct Marketing DI
- 03701521300019 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Bi-Lateral Impactor by Companion Spine France SAS — Class I — 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 | 37015213FDMN00054Z | Class I | Active |
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Manufacturer
- Manufacturer
- Companion Spine France SAS
- EUDAMED SRN
- FR-MF-000013875
Sources (2)
- EUDAMED 0ff5f30e-4244-4901-a29c-297f6b7011a4 61 fields · synced Jun 19, 2026
- EUDAMED 349f5f21-7c1f-4931-9edd-44ad58c474a3 61 fields · synced Jun 19, 2026