Evolutha X
by Italfarmacia srl Italy EUDAMED
Ref ITF003/b3Model Linea SKIN-OX
EMDN P900402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0006237126 | Date30 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 1 country, as listed in EUDAMED:
- Italy
Certificates
- CSQ0006237126 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 30 Apr 2026
- Expires
- 2 Mar 2028
- Reason
- Add device or group
- CVD0013231426 Supplemented
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 30 Apr 2026
- Expires
- 2 Mar 2028
- Reason
- Add device or group
Specification
- Device Name
- Skin-Ox
- Model / Reference
- Linea SKIN-OX, ITF003/b3
- Primary DI / UDI-DI
- 08055715336472
- Basic UDI-DI
- 805571533ITF0038Z
- Direct Marketing DI
- 08055715336472
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000013116
Other devices from Italfarmacia srl
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 71e18482-67e4-4dea-a33d-ae85a36513fe