Sibelsound 400 A
by Sibel Sau EUDAMED
Active
Ref 01378
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number843603552AAUP00101Q2 | Date23 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sibelsound 400
- Model / Reference
- 01378
- Primary DI / UDI-DI
- 08436035520879
- Basic UDI-DI
- 843603552AAUP00101Q2
- Direct Marketing DI
- 08436035520879
- EMDN Code
- Z121401 Audiometers
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000000287
From the manufacturer
Manufacturer's product page: Sibelsound 400
Other devices from Sibel Sau
Properties
Show properties
Other properties (13)
- Sterile: No
- 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