Identity
- Trade Name
- F35 TRICONTROL PLUS EUDAMED
- Device Name
- ORTESI TORACO-LOMBO-SACRALI - IPERESTENSORI EUDAMED
- Model / Reference
- F35TRI-100V.XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990114733 EUDAMED
- Basic UDI-DI
- 803348865Y06030902CR EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL SPINE 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
F35 Tricontrol Plus 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 | 803348865Y06030902CR | Class I | Active |
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Manufacturer
- Manufacturer
- F.G.P. s.r.l.
- EUDAMED SRN
- IT-MF-000043862
Sources (1)
- EUDAMED 97521f31-b1bb-4d79-9646-d13c89a3004e 61 fields · synced Jun 18, 2026