Medical device licence · 113377 · Class 2
SONATA POLYSOMNOGRAPHY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 23, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113377
- Licence holder
- Dr. Fenyves Und Gut Deutschland GmbhRangendingen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 23, 2025
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PC-SOFTWARE MSV
- SONATA NEURO MODULE
- SONATA NEURO MODULE 10-20
- SONATA PATIENT RECORDER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.