Medical device licence · 76750 · Class 3
TEG HEMOSTASIS ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed April 3, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76750
- Licence holder
- Haemonetics CorporationBoston, Massachusetts, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 3, 2008
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TEG HEMOSTASIS ANALYZER - AD BOX
- TEG HEMOSTASIS ANALYZER - BOTTOM ALIGNING POINT AND STOPPER
- TEG HEMOSTASIS ANALYZER - CACL2 .2M
- TEG HEMOSTASIS ANALYZER - CALIBRATION SPRING
- TEG HEMOSTASIS ANALYZER - CONTROLS
- TEG HEMOSTASIS ANALYZER - DISPOSABLE CUPS AND PINS
- TEG HEMOSTASIS ANALYZER - INSTALLATION KIT
- TEG HEMOSTASIS ANALYZER - INSTRUMENT
- TEG HEMOSTASIS ANALYZER - KAOLIN VIALS
- TEG HEMOSTASIS ANALYZER - PLATELETMAPPING ADP ASSAY KIT
- TEG HEMOSTASIS ANALYZER - PLATELETMAPPING ARACHIDONIC ACID (AA) ASSAY KIT
- TEG HEMOSTASIS ANALYZER - PLATELETMAPPING FULL ASSAY KIT
- TEG HEMOSTASIS ANALYZER - PLATELETMAPPING MULTIPAK ASSAY KIT
- TEG HEMOSTASIS ANALYZER - REAGENT STARTER KIT
- TEG HEMOSTASIS ANALYZER - TEG ANALYTICAL SOFTWARE (TAS)
- TEG HEMOSTASIS ANALYZER - VALIDATION KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.