Medical device licence · 109841 · Class 2
SPIFE NEXUS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 28, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109841
- Licence holder
- Helena Laboratories, CorpBeaumont, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 28, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPIFE NEXUS
- SPIFE NEXUS IMMNOFIX-15 KIT
- SPIFE NEXUS IMMUNOFIX-6 KIT
- SPIFE NEXUS IMMUNOFIX-9 KIT
- SPIFE NEXUS SPLIT BETA SPE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.