Identity
- Trade Name
- PHYLOETEK 60 EUDAMED
- Device Name
- ORTESI PER GINOCCHIO - GINOCCHIERE EUDAMED
- Model / Reference
- EPY-TK60V.M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990115488 EUDAMED
- Basic UDI-DI
- 803348865Y06120902CT EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Phyloetek 60 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 | 803348865Y06120902CT | Class I | Active |
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Manufacturer
- Manufacturer
- F.G.P. s.r.l.
- EUDAMED SRN
- IT-MF-000043862
Sources (1)
- EUDAMED 95358af3-0c0f-4ffd-b269-265ac75381a0 61 fields · synced Jun 19, 2026