Medical device licence · 28441 · Class 2
PROFILE-II ER
Yes: licensed in Canada
Licence status Issued (active); first licensed April 6, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 28441
- Licence holder
- Medtox Diagnostics, Inc.Burlington, NC, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 6, 2001
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROFILE-II ER
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 “profile-ii”. A notice may cover another product or only some lots: read it to see what it covers.
- Profile-II A (2014-10-20)November 4, 2014 · Health products · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.