Medical device licence · 3776 · Class 3
BLOOD COAG ANALYZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 28, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 3776
- Licence holder
- Sysmex CorporationKobe, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- May 28, 1999
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUTOMATED BLOOD COAGULATION ANALYZER CA-600 SERIES CA-620
- AUTOMATED BLOOD COAGULATION ANALYZER CA-600 SERIES CA-660
- SYSMEX AUTOMATED BLOOD COAGULATION ANALYZER CS-2500
- SYSMEX BLOOD COAGULATION ANALYZER CA-1500
- SYSMEX BLOOD COAGULATION ANALYZER CS-2000I
- SYSMEX BLOOD COAGULATION ANALYZER CS-2100I
- SYSMEX BLOOD COAGULATION ANALYZER CS-5100
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.