Medical device licence · 10645 · Class 2
OPTI CCA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 25, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 10645
- Licence holder
- Opti Medical Systems, Inc.Roswell, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 25, 1999
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- KIT, CARTRIDGE,PERI-PUMP, OPTI
- OPTI CCA BLOOD GAS AND ELECTROLYTE ANALYZER
- OPTI CCA CALIBRATION GAS
- OPTI CCA CASSETTE
- OPTI CCA CASSETTE B-TYPE
- OPTI CCA CASSETTE E-CA TYPE
- OPTI CCA CASSETTE E-CL TYPE
- OPTI CCA CASSETTE E-GLU TYPE
- OPTI CCA CASSETTE E-TYPE
- OPTI CCA-TS BLOOD GAS AND ELECTROLYTE ANALYZER W/TOUCH
- OPTI CCA-TS CASSETTE B-LAC TYPE
- OPTI CCA-TS CASSETTE E-BUN TYPE
- OPTI CHECK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.