Medical device licence · 83837 · Class 2
NAPSIN A
Yes: licensed in Canada
Licence status Issued (active); first licensed August 31, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83837
- Licence holder
- Biocare Medical, LlcPacheco, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 31, 2010
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NAPSIN A (CONCENTRATED MONOCLONAL ANTIBODY)
- NAPSIN A (PREDILUTED MONOCLONAL ANTIBODY)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.