Medical device licence · 95848 · Class 2
CRANIAL/ENT INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed December 22, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95848
- Licence holder
- Brainlab SeMunich, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 22, 2015
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CIRQ ROBOTIC BIOPSY BONE ANCHOR CRANIAL
- CIRQ ROBOTIC BIOPSY DRILL BIT 3.4 CRANIAL
- CIRQ ROBOTIC BIOPSY GUIDE TUBE CRANIAL
- EM PATIENT REFERENCE
- EM POINTER ENT
- EM REGISTRATION POINTER
- EM SHORT POINTER
- ERASER POINTER TIP (CURVED)
- ERASER POINTER TIP (STRAIGHT)
- HANDLE FOR MULTIPLE TIP POINTER
- INSTRUMENT ADAPTER EM
- INSTRUMENT CALIBRATION MATRIX
- POINTER BLUNT TIP
- POINTER TIP
- POINTER TIP STRAIGHT BLUNT
- SOFTOUCH REGISTRATION POINTER
- SUCTION FRONTAL SINUS, STARLINK INTERFACE
- SUCTION MAXILLARY SINUS, STARLINK INTERFACE
- SUCTION STANDARD, STARLINK INTERFACE
- Z-TOUCH LASER REGISTRATION POINTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.