Medical device licence · 98258 · Class 2
CATSMART
Yes: licensed in Canada
Licence status Issued (active); first licensed December 19, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98258
- Licence holder
- Fresenius Kabi AgBad Homburg, Hessen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 19, 2016
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AT1 AUTOTRANSFUSION SET
- AT3 AUTOTRANSFUSION SET
- ATF 120 FAST START KIT
- ATF 40 FAST START KIT
- ATV - F140C VACUUM LINES COMBI-PACK
- ATV VACUUM LINE
- ATY Y-ADAPTER
- CATSMART
- PSQ SET
- REINFUSION BAG
- VACUUM-UNIT FOR CATSMART
- WASTE BAG
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “catsmart”. A notice may cover another product or only some lots: read it to see what it covers.
- CATSmart (2019-04-11)April 18, 2019 · Medical devices · Medical devices · Type II
- Vacuum Unit for CATSmart (2019-02-18)March 1, 2019 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.