Eu Mdd
Eu Md Class 2a
On The Market
๐จ๐ฆ Canada
MediByte Jr
Devices (same UDI-DI)
1
Certificates
1
Countries
5
Notified Bodies
1
Basic Information
- Primary DI
- B140MBJR0
- Basic UDI-DI Code
- B-B140MBJR0
- Reference
- MBJR
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- BRAEBON Medical Corporation
Additional Description
The MediByte Jr is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the auto assist software enables the trained human professional -typically a Registered Sleep Technologist or Medical Doctor - to review and verify the results of the study and generate a report.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12100501 | POLYSOMNOGRAPHS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41314634 | INTERTEK SEMKO AB | Expired |
Available In Countries
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ต๐น Portugal
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