Medical device licence · 113759 · Class 2
STANDARD EXPANDER
Yes: licensed in Canada
Licence status Issued (active); first licensed August 6, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113759
- Licence holder
- Specialty AppliancesCumming, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 6, 2025
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HYRAX RPE CLICK
- HYRAX RPE NON-CLICK
- LOWER FIXED CLICK EXPANDER
- LOWER FIXED NON-CLICK EXPANDER
- MDA W/ EXPANDER
- MINI HYRAX RPE CLICK
- MINI HYRAX RPE NON-CLICK
- NAVARRO - MDA W/ EXPANDER
- PHD W/ EXPANDER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.