Medical device licence · 102756 · Class 2
DR400 PATCH RECORDER
Yes: licensed in Canada
Licence status Issued (active); first licensed April 16, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102756
- Licence holder
- Northeast Monitoring, Inc.Maynard, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 16, 2019
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1-LEAD EXTENDED PATIENT LEAD WIRE
- 3-LEAD PATIENT CABLE ADAPTER
- DR400 PATCH RECORDER
- ELECTRODE 3L PATCH
- ELECTRODE PATCH 2L
- ELECTRODE PATCHES
- PATIENT CABLE ADAPTER
- PATIENT LEAD WIRE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.