rinoLYSYAL® Spray 10 ml
by SILDEHA Swiss SA EUDAMED
Active
Ref SDA03NS01V10
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0025240225 | Date27 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CSQ0025240225 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 27 Nov 2025
- Expires
- 14 Jul 2029
- Reason
- Add device or group
Specification
- Device Name
- sT-LysYal® Soluzione Sterile Spray Nasale
- Model / Reference
- SDA03NS01V10
- Primary DI / UDI-DI
- 07640449380047
- Basic UDI-DI
- 764044938STLYSOLRINHY
- EMDN Code
- M040499 Dressings for wounds, sores and ulcerations - other
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CH-MF-000034348
- Authorised representative
- SILDEHA Pharma Srl IT-AR-000029496
Other devices from SILDEHA Swiss SA
Properties
Other properties (12)
- Implantable: No
- 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