Identity
- Trade Name
- M.4®s OA COMFORT EUDAMED
- Device Name
- ORTESI PER GINOCCHIO - GINOCCHIERE OA EUDAMED
- Model / Reference
- M4 S OA COMF VALGO SXV.XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990112081 EUDAMED
- Basic UDI-DI
- 803348865Y06120905CZ EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
M.4®s OA COMFORT by F.G.P. s.r.l. — 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 | 803348865Y06120905CZ | Class I | Active |
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Manufacturer
- Manufacturer
- F.G.P. s.r.l.
- EUDAMED SRN
- IT-MF-000043862
Sources (1)
- EUDAMED bae9ef35-1eaf-4921-b7b4-da7d50265a1b 61 fields · synced Jun 18, 2026