Medical device licence · 113206 · Class 2
C-ERB-2/HER2
Yes: licensed in Canada
Licence status Issued (active); first licensed May 1, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113206
- Licence holder
- Biocare Medical, LlcPacheco, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 1, 2025
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- C-ERBB-2/HER2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.