Medical device licence · 76397 · Class 2
SED-CHEK 2 CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed February 19, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76397
- Licence holder
- Polymedco Inc., Polymedco Cancer Diagnostic Products, LlcCortlandt Manor, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- February 19, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SED-CHEK 2 FOR MANUAL OR SEDIMAT METHODS
- SED-CHEK 2 FOR SEDIMAT 15
- SED-CHEK 2 FOR STARRSED SELECT MODELS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.