Medical device licence · 93263 · Class 4
EXTERNAL PACEMAKERS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 15, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93263
- Licence holder
- Osypka Medical GmbhBerlin, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- May 15, 2014
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DUAL CHAMBER EXTERNAL PACEMAKER
- SINGLE CHAMBER EXTERNAL PACEMAKER
- TRIPLE CHAMBER EXTERNAL PACEMAKER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.