Medical device licence · 76565 · Class 3
FABIUS MRI (ANESTHESIA WORKSTATION)
Yes: licensed in Canada
Licence status Issued (active); first licensed March 14, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76565
- Licence holder
- Draegerwerk Ag & Co. KgaaLubeck, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- March 14, 2008
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FABIUS MRI
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 “fabius”. A notice may cover another product or only some lots: read it to see what it covers.
- FABIUS SYSTEM (2021-07-01)July 16, 2021 · Medical devices · Medical devices · Type II
- FABIUS Tiro Anesthesia System, GS Premium System and MRI (2017-11-01)November 15, 2017 · Medical devices · Medical devices · Type I
- FABIUS MRI (2015-06-15)July 9, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.