Eu Mdr
Eu Md Class 2a
On The Market
Bittium Respiro HSAT System
The device is intended to be used as an ambulatory recording device for overnight polygraphy, which is always carried out by doctor’s prescription.
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06430035221059
- Basic UDI-DI Code
- 643003522RespiroHSATSPPGQ
- Reference
- S0000021617
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
Additional Description
Bittium Respiro HSAT System is the highest level of definition of Bittium Respiro Product portfolio. System is a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.
Medical Purpose
The device is intended to be used as an ambulatory recording device for overnight polygraphy, which is always carried out by doctor’s prescription.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V0399 | MEASUREMENT DEVICES - OTHER |
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