Medical device licence · 107146 · Class 4
RENAMIC NEO
Yes: licensed in Canada
Licence status Issued (active); first licensed December 15, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107146
- Licence holder
- Biotronik Se & Co. KgBerlin, 11, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- December 15, 2021
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NEO 2301.A/1
- NEO 2302.A/1
- NEO SOFTWARE
- PATIENT ADAPTER
- PATIENT CABLE
- PK-222 US
- PK-222-L ECG CABLE US
- PK-ELECTRODE CLIP
- POWER CORD NK-41
- POWER SUPPLY BRICK (RENAMIC NEO)
- RECHARGEABLE BATTERY (RENAMIC NEO)
- RENAMIC NEO
- RENAMIC NEO PGH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.