Medical device licence · 108590 · Class 3
ZAFFIRO
Yes: licensed in Canada
Licence status Issued (active); first licensed November 28, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108590
- Licence holder
- Neauvia North America, Inc.Raleigh, NC, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 28, 2022
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ZAFFIRO 220 POWER CORDS
- ZAFFIRO CANNULA
- ZAFFIRO FOOT SWITCH
- ZAFFIRO HANDSET CABLES AND QUICK CONNECTORS CORD
- ZAFFIRO IR HP ASSEMBLY
- ZAFFIRO IR TREATMENT BODY APPLICATOR
- ZAFFIRO POWER CONVERTER
- ZAFFIRO SYSTEM
- ZAFFIRO WP HE HANDPIECE AND TIP
- ZAFFIRO WP HP CARTRIDGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.