Medical device licence · 114010 · Class 2
PRINTED EXPANDER
Yes: licensed in Canada
Licence status Issued (active); first licensed September 23, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114010
- Licence holder
- Specialty AppliancesCumming, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 23, 2025
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRINTED HYRAX RPE CLICK
- PRINTED HYRAX RPE NON-CLICK
- PRINTED LOWER FIXED CLICK EXPANDER
- PRINTED LOWER FIXED NON-CLICK EXPANDER
- PRINTED MINI HYRAX RPE CLICK
- PRINTED MINI HYRAX RPE NON-CLICK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.