Medical device licence · 115812 · Class 4
HEARTON A16 AED FULLY-AUTOMATIC
Yes: licensed in Canada
Licence status Issued (active); first licensed July 20, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115812
- Licence holder
- Mediana Co., Ltd.Seoul, South Korea
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 20, 2026
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADHESIVE PAD
- AUTOMATED EXTERNAL DEFIBRILLATOR PADS
- CPR FEEDBACK INTERFACE MODULE
- HEARTON A16-GF
- HEARTON A16-GF NON-RECHARGEABLE BATTERY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.