Identity
- Trade Name
- FITOFIX NEOPRENE GOMITIERA - L EUDAMED
- Device Name
- DISPOSITIVI IN NEOPRENE EUDAMED
- Model / Reference
- FX3016/L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08031255008543 EUDAMED
- Basic UDI-DI
- 80312550009K4 EUDAMED
- EMDN Code
- Y090612 ARM AND ELBOW PROTECTIONS 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
Fitofix Neoprene Gomitiera - L by Phyto Performance Italia Srl — 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 | 80312550009K4 | Class I | Active |
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Manufacturer
- Manufacturer
- Phyto Performance Italia Srl
- EUDAMED SRN
- IT-MF-000008118
Sources (1)
- EUDAMED dd77cf1d-0944-482e-8074-5662d2af1f59 61 fields · synced Jul 20, 2026