Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 07350170210000
- Basic UDI-DI Code
- 735017021SensoDetectZA
- Reference
- A1000-4
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Sensodetect AB
Additional Description
The SensoDetect® BERA device is a brainstem audiometer (ABR - Auditory Brainstem Response) that records brainstem activity from the auditory neural pathways. The product is designed for use on patients of all ages, from infants to the elderly, as a hearing test based on ABR visual analysis by medical professionals in a clinical setting (a silent room with minimal interference).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12140301 | EVOKED POTENTIAL AUDIOMETRY INTEGRATED SYSTEMS |
Available In Countries
🇸🇪 Sweden
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