Medical device licence · 113897 · Class 2
INFUSOMAT SPACE LINE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 29, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113897
- Licence holder
- B. Braun Melsungen AgMelsungen, Hessen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- August 29, 2025
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INFUSOMAT SPACE LINE
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 “infusomat”. A notice may cover another product or only some lots: read it to see what it covers.
- B. Braun IV Administration Sets & Infusomat® Space® Administration SetsOctober 23, 2025 · General hospital and personal use · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.