Medical device licence · 93387 · Class 2
HYDRA IRRIGATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 11, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93387
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 11, 2014
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HYDRA IRRIGATION TUBING
- HYDRA OLYMPUS DISPOSABLE AUXILIARY IRRIGATION PORT CONNECTOR
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 “hydra”. A notice may cover another product or only some lots: read it to see what it covers.
- Hydra Vision Urology System and Direct Digital Imaging System (2018-10-07)December 10, 2018 · 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.