Medical device licence · 101763 · Class 3
COAGUCHEK INRANGE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 21, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101763
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 21, 2018
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COAGUCHEK INRANGE
- COAGUCHEK XS PT TEST PST
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 “coaguchek”. A notice may cover another product or only some lots: read it to see what it covers.
- Coaguchek XS Strips (2018-10-10)November 28, 2018 · 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.