Identity
- Trade Name
- M.4s OA COMFORT SHORT EUDAMED
- Device Name
- ORTESI PER GINOCCHIO - GINOCCHIERE OA EUDAMED
- Model / Reference
- M4SOACOMFSH.VALGO.SX.XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990116980 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.4s OA COMFORT SHORT 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 b2ceb680-7d80-4bc2-8a10-88ca6943ce97 61 fields · synced Jun 19, 2026