Medical device licence · 81420 · Class 3
BILIARY STENT
Yes: licensed in Canada
Licence status Issued (active); first licensed December 8, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81420
- Licence holder
- M.I. Tech Co., Ltd.Pyeongtaek-Si, GD, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- December 8, 2009
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HANAROSTENT BENEFIT BILIARY (NNN)
- HANAROSTENT BILIARY (CCC)
- HANAROSTENT BILIARY (NC)
- HANAROSTENT BILIARY (NCN)
- HANAROSTENT BILIARY (NNN)
- HANAROSTENT BILIARY FLAP (CCC)
- HANAROSTENT BILIARY FLAP LASSO (CCC)
- HANAROSTENT BILIARY HILAR (NNN)
- HANAROSTENT BILIARY LASSO (CCC)
- HANAROSTENT BILIARY LASSO (NNN)
- HANAROSTENT FAST BILIARY (NCN)
- HANAROSTENT FAST BILIARY (NNN)
- HANAROSTENT FAST BILIARY FLAP (CCC)
- HANAROSTENT FAST BILIARY LASSO (CCC)
- HANAROSTENT MULTI-HOLE BILIARY (CCC)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.