Medical device licence · 81402 · Class 3
TEARLAB OSMOLARITY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 7, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81402
- Licence holder
- Trukera MedicalTemecula, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 7, 2009
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TEARLAB OSMOLARITY SYSTEM - ELECTRONIC CHECK CARDS
- TEARLAB OSMOLARITY SYSTEM - MAIN
- TEARLAB OSMOLARITY SYSTEM - OSMOLARITY CONTROLS
- TEARLAB OSMOLARITY SYSTEM - OSMOLARITY TEST CARDS - DISPOSABLE
- TEARLAB OSMOLARITY SYSTEM - PEN
- TEARLAB OSMOLARITY SYSTEM - READER INSTRUMENT
- TEARLAB OSMOLARITY SYSTEM - TCI CARD AND CARD CAPSULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.