Identity
- Trade Name
- GOMITIEA MANICOTTO - XL EUDAMED
- Device Name
- DISPOSITIVI IN NEOPRENE EUDAMED
- Model / Reference
- P3013/XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08031255038601 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
Gomitiea Manicotto - Xl 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phyto Performance Italia Srl
- EUDAMED SRN
- IT-MF-000008118
Sources (1)
- EUDAMED 0d32d308-3e00-4e41-986d-15c2dece3dd0 61 fields · synced Jul 28, 2026