Identity
- Device Name
- IMPACTOR EUDAMED
- Model / Reference
- 920-0012-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701037311905 EUDAMED
- Basic UDI-DI
- 37010373IMPACTORNW EUDAMED
- Direct Marketing DI
- 03701037311905 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE 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
Impactor 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 | 37010373IMPACTORNW | Class I | Active |
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Manufacturer
- Manufacturer
- FX Shoulder Solutions
- EUDAMED SRN
- FR-MF-000000465
Sources (1)
- EUDAMED 90d42742-5b15-49b2-a400-fd15ba6c8c5d 61 fields · synced Jul 8, 2026