Medical device licence · 80503 · Class 2
NAVIOS FLOW CYTOMETER
Yes: licensed in Canada
Licence status Issued (active); first licensed August 18, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80503
- Licence holder
- Beckman Coulter Ireland, Inc.Co. Clare, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 18, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NAVIOS 10 COLORS / 3 LASERS
- NAVIOS 6 COLORS / 2 LASERS
- NAVIOS 8 COLORS / 2 LASERS
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 “navios”. A notice may cover another product or only some lots: read it to see what it covers.
- Navios Lasers (2013-10-16)November 25, 2013 · Medical devices · Medical devices · Type III
- Navios Lasers (2013-08-22)October 25, 2013 · Medical devices · Medical devices · Type III
- Navios Color Lasers (2013-05-30)October 16, 2013 · Medical devices · Medical devices · Type III
- Navios 8 and 10 Colour Lasers (2013-08-28)September 19, 2013 · Medical devices · Medical devices · Type III
- Navios ProductsDecember 17, 2012 · Medical devices · Type II
- Navios Flow Cytometry Software (two different models)October 24, 2011 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.