Medical device licence · 85893 · Class 2
BIO-FLASH SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 21, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85893
- Licence holder
- Biokit S.A.Lliçà D'Amunt, 08, Spain
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 21, 2011
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIO-FLASH ANALYZER
- BIO-FLASH CUVETTES
- BIO-FLASH SAMPLE DILUENT
- BIO-FLASH SYSTEM CLEANING SOLUTION
- BIO-FLASH SYSTEM RINSE
- BIO-FLASH TRIGGERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.