Medical device licence · 107045 · Class 2
CALIAGOLD
Yes: licensed in Canada
Licence status Issued (active); first licensed November 26, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107045
- Licence holder
- Sentinel Ch. SpaMilan, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 26, 2021
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALIAGOLD
- CALIAGOLD CALIBRATOR SET
- CALIAGOLD CONTROL SET
- CALIAGOLD PIERCE TUBE
- CALIAGOLD RV
- CALIAGOLD SAMPLE DILUENT
- CALIAGOLD TUBE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “caliagold”. A notice may cover another product or only some lots: read it to see what it covers.
- CALiaGold PierceTubeJuly 4, 2024 · Chemistry · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.