Medical device licence · 97213 · Class 2
COMBISTAR
Yes: licensed in Canada
Licence status Issued (active); first licensed June 25, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97213
- Licence holder
- Draegerwerk Ag & Co. KgaaLubeck, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 25, 2016
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMBISTAR F-HME HEPA FLEX
- COMBISTAR F-HME HEPA STRAIGHT
- COMBISTAR FILTER FLEX
- COMBISTAR FILTER HME FLEX
- COMBISTAR FILTER HME STRAIGHT
- COMBISTAR FILTER STRAIGHT
- COMBISTAR MECH, FILTER FLEX
- COMBISTAR MECH, FILTER STRAIGHT
- COMBISTAR PLUS FILTER + HME FLEX
- COMBISTAR PLUS FILTER + HME HEPA FLEX
- COMBISTAR PLUS FILTER + HME STRAIGHT
- COMBISTAR PLUS FILTER FLEX
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 “combistar”. A notice may cover another product or only some lots: read it to see what it covers.
- CombiStar, SafeStar and TwinStar Filters/ HMEsJune 10, 2025 · Anaesthesiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.