Medical device licence · 82683 · Class 2
XTRA
Yes: licensed in Canada
Licence status Issued (active); first licensed April 26, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82683
- Licence holder
- Sorin Group Italia S.R.L.Mirandola, MO, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 26, 2010
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GOCCIA MICRO MICROAGGREGATE FILTER
- GOCCIA MICRO MICROAGGREGATE FILTER W.LINE
- TANDEM RESERVOIR "Y"
- WB10 WASTE BAG X 10LT
- XTRA AUTOTRANSFUSION SYSTEM - BOWL SETS
- XTRA AUTOTRANSFUSION SYSTEM - PROCEDURE SETS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.