Medical device licence · 111870 · Class 3
ANYONE EXTERNAL IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 26, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111870
- Licence holder
- Megagen Implant Co., Ltd.Daegu, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 26, 2024
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABUTMENT SCREW [EX/EZ]
- ANGLED ABUTMENT [EX/EZ]
- ANYONE EXTERNAL FIXTURE
- COVER SCREW [EX/EZ]
- ESTHETIC HEALING ABUTMENT [EX]
- EZ POST ABUTMENT [EX/EZ]
- HEALING ABUTMENT [EX/EZ]
- MEG-RHEIN ABUTMENT [EX]
- MILLING ABUTMENT [EX/EZ]
- MULTI-UNIT ABUTMENT SCREW [AO]
- MULTI-UNIT ABUTMENT SET
- MULTI-UNIT ABUTMENT [AE]
- MULTI-UNIT ANGLED ABUTMENT [AE]
- PLASTIC ABUTMENT [EX/EZ]
- REGULAR ABUTMENT SCREW [EX]
- REGULAR ABUTMENT [EX/EZ]
- TEMPORARY ABUTMENT [EX/EZ]
- TIGEN ABUTMENT [AE]
- ZRGEN ABUTMENT [EX]
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.