Medical device licence · 84415 · Class 2
BREATHING FILTERS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 10, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84415
- Licence holder
- Sunmed Holdings, LlcGrand Rapids, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 10, 2010
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FILTER, BACTERIAL/VIRAL
- FILTER, GSL
- GAS SAMPLING LINE, FILTER, 0.8 MICRON
- HEPA FILTER WITH ELBOW
- HEPA FILTER, W CO2 PORT
- HEPA FILTER, W/O CO2 PORT
- HME FILTER, ANGLED WITH LUER PORT
- HME FILTER, IN-LINE MINI W/SAMPLING PORT
- HME, ANGLED WITH LUER PORT
- HME, IN-LINE MINI
- IN-LINE MAXI HME FILTER W/O PORT
- IN-LINE MAXI HME FILTER W/SAMPLING PORT
- INFANT HMEF W/SAMPLING PORT
- PFT FILTER ASSEMBLY, ELLIPTICAL W/MACHINE FITTING
- PFT FILTER ASSEMBLY, ROUND W/MACHINE FITTING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.