Medical device licence · 61385 · Class 2
SEALFLEX MASKS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 7, 2003; ended October 26, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61385
- Licence holder
- Engineered Medical Systems Inc.Indianapolis, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- January 7, 2003
- Ended
- October 26, 2010
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT SEALFLEX SINGLE PORT PVC MASK
- ADULT SEALFLEX SINGLE PORT TPE MASK
- CHILD SEALFLEX SINGLE PORT PVC MASK
- CHILD SEALFLEX SINGLE PORT TPE MASK
- INFANT SEALFLEX SINGLE PORT PVC MASK
- INFANT SEALFLEX SINGLE PORT TPE MASK
- NEONATAL SEALFLEX SINGLE PORT PVC MASK
- NEONATAL SEALFLEX SINGLE PORT TPE MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.