Sinosun spray (SP2T-003)
by Enable Innovations SRL Italy EUDAMED
Ref 050225Model Spray nasale SP2T EMDN Q030199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number80540851213NQ | Date15 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 0425-MDR-030120-00 Issued
Quality management system EU MDR
- Notified body
- ICIM S.P.A. 0425
- Issued
- 3 Feb 2025
- Expires
- 2 Feb 2030
Specification
- Device Name
- Spray nasale SP2T
- Model / Reference
- Spray nasale SP2T, 050225
- Primary DI / UDI-DI
- 06425746002639
- Basic UDI-DI
- 80540851213NQ
- EMDN Code
- Q030199 Nasopharyngeal devices - other
- Device Class
- Class IIa
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- IT-MF-000026066
Other devices from Enable Innovations SRL
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 338a53eb-d008-4e06-a67c-11e7c58ad4ed