Medical device licence · 88694 · Class 2
MYOSURE HYSTEROSCOPY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 88694
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 18, 2012
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MYOSURE HYSTEROSCOPY SET
- MYOSURE REMOVABLE OUTFLOW CHANNEL
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 “myosure”. A notice may cover another product or only some lots: read it to see what it covers.
- Hologic MyoSure Rod Lens Hysteroscope (2017-12-11)December 21, 2017 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.