Medical device licence · 113487 · Class 2
URETHRAL DILATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed June 12, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113487
- Licence holder
- Well Lead Medical Co., Ltd.Guangzhou, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 12, 2025
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HYDROPHILIC COATING DILATOR
- HYDROPHILIC COATING S SHAPE DILATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.