Medical device licence · 99195 · Class 2
DIA-X FILE
Yes: licensed in Canada
Licence status Issued (active); first licensed May 18, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99195
- Licence holder
- Diadent Group InternationalChungcheongbuk-Do, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 18, 2017
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIA-X FILE (19 MM)
- DIA-X FILE (21 MM)
- DIA-X FILE (25 MM)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.