Medical device licence · 101022 · Class 2
INCOGNITO APPLIANCE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 10, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101022
- Licence holder
- 3M Unitek CorporationMonrovia, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 10, 2018
- Devices covered
- 27
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INCOGNITO APPLIANCE SYSTEM
- INCOGNITO APPLIANCE SYSTEM 2 PHASE SILICONE TRAY
- INCOGNITO APPLIANCE SYSTEM BRACKET POST SCAN
- INCOGNITO APPLIANCE SYSTEM BRACKET POST SCAN ADDITIONAL
- INCOGNITO APPLIANCE SYSTEM BRACKET REPLACEMENT
- INCOGNITO APPLIANCE SYSTEM BRACKET WITH DIGITAL SETUP
- INCOGNITO APPLIANCE SYSTEM BRACKET WITH DIGITAL SETUP SCAN
- INCOGNITO APPLIANCE SYSTEM BRACKET WITH MANUAL SETUP
- INCOGNITO APPLIANCE SYSTEM CAST BAND
- INCOGNITO APPLIANCE SYSTEM CAST BAND FOR FORSUS/ HERBST
- INCOGNITO APPLIANCE SYSTEM CLEAR PRECISION TRAY
- INCOGNITO APPLIANCE SYSTEM HERBST SET
- INCOGNITO APPLIANCE SYSTEM LABIAL ATTACHMENT FOR FORSUS
- INCOGNITO APPLIANCE SYSTEM LITE 2 PHASE SILICONE TRAY
- INCOGNITO APPLIANCE SYSTEM LITE BRACKET
- INCOGNITO APPLIANCE SYSTEM LITE BRACKET WITH SCAN
- INCOGNITO APPLIANCE SYSTEM LITE CLEAR PRECISION TRAY
- INCOGNITO APPLIANCE SYSTEM LITE SPLINT
- INCOGNITO APPLIANCE SYSTEM LITE THERMOPLASTIC TRAY
- INCOGNITO APPLIANCE SYSTEM PAD BLOCK
- INCOGNITO APPLIANCE SYSTEM THERMOPLASTIC TRAY
- INCOGNITO APPLIANCE SYSTEM WIRE - BETA III TITANIUM
- INCOGNITO APPLIANCE SYSTEM WIRE - CU NITI
- INCOGNITO APPLIANCE SYSTEM WIRE - SE NITI
- INCOGNITO APPLIANCE SYSTEM WIRE - SS
- INCOGNITO APPLIANCE SYSTEM WIRE - TMA
- INCOGNITO CLEANING OF BRACKETS AND/OR REPOSITIONING OF BRACKETS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.