Medical device licence · 109893 · Class 2
AMIKA+
Yes: licensed in Canada
Licence status Issued (active); first licensed August 11, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109893
- Licence holder
- Fresenius Kabi AgBad Homburg, Hessen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 11, 2023
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMIKA BAG MOBILE, ENFIT
- AMIKA BAG WITH COVER, ENFIT
- AMIKA EASYBAG, ENFIT
- AMIKA PUMP SET BAG MOBILE, UNIVERSAL, ENFIT
- AMIKA PUMP SET BAG, UNIVERSAL, ENFIT
- AMIKA PUMP SET EASYBAG, UNIVERSAL, ENFIT
- AMIKA PUMP SET VARIOLINE, UNIVERSAL, ENFIT
- AMIKA VARIOLINE WITH COVER, ENFIT
- AMIKA+ CDN ENTERAL FEEDING PUMP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.