Medical device licence · 91139 · Class 3
UTASWAKO I30
Yes: licensed in Canada
Licence status Issued (active); first licensed April 23, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91139
- Licence holder
- Fujifilm Wako Pure Chemical CorporationOsaka, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- April 23, 2013
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UTASWAKO CHIP CASSETTE
- UTASWAKO I30
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 “utaswako”. A notice may cover another product or only some lots: read it to see what it covers.
- uTASWako DCP and uTASWako AFP-L3 (2018-07-27)August 31, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.