Medical device licence · 93481 · Class 2
INTEGO INTEGO PRO
Yes: licensed in Canada
Licence status Issued (active); first licensed July 2, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93481
- Licence holder
- Sirona Dental Systems GmbhBensheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- July 2, 2014
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INTEGO
- INTEGO PRO
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 “intego”. A notice may cover another product or only some lots: read it to see what it covers.
- Medrad Intego PET Infusion System - Source Administration SetsNovember 18, 2016 · Medical devices · Medical devices · Type I
- MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINIOctober 5, 2016 · Medical devices · Type II
- MEDRAD INTEGO PET INFUSION SYSTEM - MAIN (2016-05-31)June 13, 2016 · Medical devices · Medical devices · Type II
- Medrad Intego Pet Infusion System - Source Admini (2015-11-30)February 1, 2016 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.