Medical device licence · 106988 · Class 2
REUSABLE SURGICAL INSTRUMENT
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106988
- Licence holder
- Cowellmedi Co., Ltd.Busan, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- November 18, 2021
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATRANUMATIC EXTRACTION KIT
- COWELL BMP TREPHINE KIT
- COWELL PROSTHETIC KIT
- DIRECT SURGICAL GUIDE KIT
- INNO EXT. FULL SURGICAL KIT
- INNO INT. FULL SURGICAL KIT
- INNO SUB. FULL KIT
- INNO SUB. NARROW KIT
- INNO SUB. SMART KIT
- INNO SUB.SHORT KIT
- INNOFIT LODESTAR KIT
- INNOFIT LODESTAR PLUS KIT
- INNOGENIC AUTOBONE HARVESTER
- INNOGENIC GBR KIT
- MINI SURGICAL KIT
- MULTI-FUNCTIONAL REMOVAL KIT
- MULTI-FUNCTIONAL SINUS KIT
- SCREW KIT
- SINUS LIFT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.