Medical device licence · 98903 · Class 3
IBDOC
Yes: licensed in Canada
Licence status Issued (active); first licensed April 6, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98903
- Licence holder
- Buhlmann Laboratories AgSchonenbuch, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 6, 2017
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALAPP
- IBDOC CALPROTECTIN
- IBDOC CALPROTECTIN KIT
- IBDOC CALPROTECTIN STARTER KIT
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 “ibdoc”. A notice may cover another product or only some lots: read it to see what it covers.
- IBDoc Calprotectin, IBDoc Calprotectin Kit (2019-03-19)April 5, 2019 · Medical devices · Medical devices · Type II
- IBDoc Calprotectin Kit, Starter Kit and CalApp (2018-02-27)April 3, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.