Medical device licence · 88385 · Class 3
PRECICONTROL HE4
No longer licensed: cancelled
Licence status Cancelled; first licensed March 5, 2012; ended March 29, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 88385
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group
- First licensed
- March 5, 2012
- Ended
- March 29, 2019
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRECICONTROL HE4
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 “precicontrol”. A notice may cover another product or only some lots: read it to see what it covers.
- PreciControl VariaJanuary 18, 2017 · Medical devices · Type III
- PreciControl Multimaker (2014-12-16)January 14, 2015 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.