ApprovalTrail

Medical device licence · 80535 · Class 2

NITRIC OXIDE THERAPY REGULATOR

Yes: licensed in Canada

Licence status Issued (active); first licensed August 21, 2009. It is in Health Canada’s list of active licences.
Licence number
80535
Licence holder
Mallinckrodt Manufacturing LlcHampton, NJ, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 21, 2009
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • INOMAX REGULATOR

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.