Medical device licence · 63699 · Class 2
BIO-POTENTIAL ELECTRODES
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed February 6, 2004; ended November 3, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63699
- Licence holder
- Rochester Electro-Medical, Inc.Coral Springs, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- February 6, 2004
- Ended
- November 3, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIO-POTENTIAL RIBBON ELCTRODES
- BIO-POTENTIAL SILICONE WIRE ELECTRODES
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “bio-potential”. A notice may cover another product or only some lots: read it to see what it covers.
- Bio-potential Signal Acquisition SystemNovember 9, 2016 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.