Medical device licence · 97753 · Class 2
PNEUMOCLEAR
Yes: licensed in Canada
Licence status Issued (active); first licensed September 26, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97753
- Licence holder
- Novanta Medical GmbhBerlin, 11, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 26, 2016
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER FOR UNIVERSAL GAS CONNECTION
- HIGH PRESSURE HOSE
- HOSE FOR CO2 CENTRAL GAS SUPPLY
- PNEUMOCLEAR
- PNEUMOCLEAR TUBE SETS
- SINTER FILTER FOR UNIVERSAL GAS CONNECTION
- SWITCHING VALVE FOR INSUFFLATORS
- UNIVERSAL GAS CONNECTOR
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “pneumoclear”. A notice may cover another product or only some lots: read it to see what it covers.
- PneumoClear (2018-10-18)March 8, 2019 · Medical devices · Medical devices · Type III
- PNEUMOCLEAR Heated High-Flow Tube Set (2018-10-21)November 28, 2018 · Medical devices · Medical devices · Type III
- PneumoClear (2017-11-13)January 12, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.