Medical device licence · 113765 · Class 3
DIALOG IQ HDF
Yes: licensed in Canada
Licence status Issued (active); first licensed August 6, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113765
- Licence holder
- B. Braun Avitum AgMelsungen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 6, 2025
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BRAUN CUFF FOR ABPM
- CCS (CENTRAL CONCENTRATE SUPPLY)
- COMM-NEXADIA (NETWORK INTERFACE)
- DIALOG IQ DIALYSIS MACHINE
- DIASTREAM IQ ACCESSORY HDF
- DIASTREAM IQ CLASSIC
- DIASTREAM IQ PREMIUM
- HCT SENSOR (HEMATOCRIT SENSOR)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.