Medical device licence · 103611 · Class 2
HYPERINFLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 16, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103611
- Licence holder
- Sunmed Holdings, LlcGrand Rapids, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- September 16, 2019
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISPOSABLE BREATHING BAG
- HYPERINFLATION SYSTEM
- HYPERINFLATION SYSTEM + MANOMETER
- HYPERINFLATION SYSTEM + MANOMETER + MASK
- HYPERINFLATION SYSTEM + MANOMETER + H2O POP-OFF
- HYPERINFLATION SYSTEM + MANOMETER + H2O POP-OFF + MASK
- HYPERINFLATION SYSTEM + MANOMETER + H2O POP-OFF + O2 TUBING
- HYPERINFLATION SYSTEM + MASK
- HYPERINFLATION SYSTEM ELBOW + MANOMETER
- HYPERINFLATION SYSTEM ELBOW + O2 TUBING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.