Medical device licence · 106259 · Class 2
DIASTREAM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 11, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106259
- Licence holder
- B. Braun Avitum AgMelsungen, --, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 11, 2021
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIASTREAM A/V BLOODLINE SYSTEMS FOR HAEMODIALYSIS
- DIASTREAM ADVANCED A/V BLOODLINE SYSTEMS FOR HAEMODIALYSIS
- DIASTREAM BASIC A/V BLOODLINE SYSTEMS FOR HAEMODIALYSIS
- DIASTREAM CLASSIC A/V BLOODLINE SYSTEMS FOR HAEMODIALYSIS
- DIASTREAM CLASSIC UNIVERSAL A/V BLOODLINE SYSTEMS FOR HAEMODIALYSIS
- DIASTREAM PREMIUM A/V BLOODLINE SYSTEMS FOR HAEMODIALYSIS
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 “diastream”. A notice may cover another product or only some lots: read it to see what it covers.
- DiaStream Classic HD SNCOMarch 25, 2025 · Gastroenterology and urology · Sterility · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.