Medical device licence · 97702 · Class 3
TEG 6S
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97702
- Licence holder
- Haemonetics CorporationBoston, Massachusetts, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 14, 2016
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABNORMAL QC TEST KIT
- CARTRIDGE REAGENT QC - LEVEL 1
- CARTRIDGE REAGENT QC - LEVEL 2
- CITRATED K, KH, RT, FF
- GLOBAL HEMOSTATSIS - HN
- PLATELET MAPPING ADP, AA
- QC LEVEL 1 10 PACK
- QC LEVEL 2 10 PACK
- SCANNER, AREA IMAGING
- TEG 6S
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.