Medical device licence · 103244 · Class 3
BLUEDIAMOND IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 19, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103244
- Licence holder
- Megagen Implant Co., Ltd.Daegu, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 19, 2019
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABUTMENT SCREW
- ANGLED ABUTMENT
- BLUEDIAMOND IMPLANT
- CCM ABUTMENT
- COVER SCREW
- EZ POST ABUTMENT
- FIXTURE MOUNT
- FUSE ABUTMENT
- HEALING ABUTMENT
- MEG-RHEIN ABUTMENT
- MEG-RHEIN OVERDENTURE SYSTEM
- MILLING ABUTMENT
- MULTI-UNIT ABUTMENT
- MULTI-UNIT ABUTMENT SCREW
- MULTI-UNIT ABUTMENT SET
- MULTI-UNIT ANGLED ABUTMENT
- OCTA ABUTMENT
- S.H.A SCREW
- SCAN HEALING ABUTMENT
- STAINLESS STEEL HOUSING
- TEMPORARY ABUTMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.