Sistema Sibelsound 400 A
by Sibel Sau EUDAMED
Active
Ref 01378-S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number843603552AAUY00101TP | Date29 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sistema Sibelsound 400
- Model / Reference
- 01378-S
- Primary DI / UDI-DI
- 08436035524242
- Basic UDI-DI
- 843603552AAUY00101TP
- EMDN Code
- Z121401 Audiometers
- Device Class
- Class IIa
- Medical Purpose
- Diagnosis and monitoring of patients with hearing loss (hypoacusia).
Manufacturer details
- EUDAMED SRN
- ES-PR-000052577
From the manufacturer
Manufacturer's product page: Sibelsound 400
Other devices from Sibel Sau
Properties
Show properties
Other properties (1)
- Sterile: No