Medical device licence · 109890 · Class 3
CIRQ ALIGNMENT CRANIAL
Yes: licensed in Canada
Licence status Issued (active); first licensed August 14, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109890
- Licence holder
- Brainlab SeMunich, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 14, 2023
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALIGNMENT BONE ANCHOR CRANIAL
- ALIGNMENT GUIDE TUBE CRANIAL 2.5/7.5
- ALIGNMENT SOFTWARE CRANIAL
- CIRQ ROBOTIC ALIGNMENT MODULE
- CIRQ ROBOTIC ALIGNMENT SOFTWARE
- CIRQ ROBOTIC BIOPSY BONE ANCHOR CRANIAL
- CIRQ ROBOTIC BIOPSY DRILL BIT 3.4 CRANIAL
- CIRQ ROBOTIC BIOPSY GUIDE TUBE CRANIAL
- CIRQ ROBOTIC DISPOSABLE KINEMATIC UNIT
- DRILL BIT CRANIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.