Identity
- Device Name
- INSTRUMENTATION SET EUDAMED
- Model / Reference
- 604-0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701037319925 EUDAMED
- Basic UDI-DI
- 37010373TRAYKL EUDAMED
- Direct Marketing DI
- 03701037319925 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
Instrumentation Set by FX Shoulder Solutions — 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 | 37010373TRAYKL | Class I | Active |
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Manufacturer
- Manufacturer
- FX Shoulder Solutions
- EUDAMED SRN
- FR-MF-000000465
Sources (1)
- EUDAMED 64a0b954-a8f0-4d9e-b9da-2bad0bed0a31 61 fields · synced Oct 6, 2026