Medical device licence · 84280 · Class 3
COLO/RECTAL STENT
Yes: licensed in Canada
Licence status Issued (active); first licensed October 28, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84280
- 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
- October 28, 2010
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CHOOSTENT COLON/RECTUM (CCC)
- HANAROSTENT COLON/RECTUM (CCC)
- HANAROSTENT COLON/RECTUM (NNN)
- HANAROSTENT COLON/RECTUM ASYMMETRIC (CCC)
- HANAROSTENT COLON/RECTUM LASSO (NNN)
- HANAROSTENT COLON/RECTUM TTS (CCC)
- HANAROSTENT INTESTINE ASYMMETRIC (NCN)
- HANAROSTENT LOWAX COLON/RECTUM (NNN)
- HANAROSTENT TWYNLAY COLONRECTUM (NCN)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.