Medical device licence · 83039 · Class 2
RENASYS PORT
Yes: licensed in Canada
Licence status Issued (active); first licensed June 10, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83039
- Licence holder
- Smith & Nephew Medical Ltd.Hull, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 10, 2010
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RENASYS SOFT PORT
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 “renasys”. A notice may cover another product or only some lots: read it to see what it covers.
- RENASYS™ EDGE Negative Pressure Wound TherapyOctober 23, 2024 · General hospital and personal use · Performance · Type II
- Renasys Edge Canister With SolidifierMarch 28, 2024 · General hospital and personal use · Performance · Type II
- RENASYS GAUZE DRESSING, FISTULA KIT and TRANSPARENT FILM (2016-07-22)August 5, 2016 · Medical devices · Medical devices · Type II
- RENASYS GO NEGATIVE PRESSURE WOUND THERAPY SYSTEM - POWER SUPPLY (2016-02-29)March 10, 2016 · Medical devices · Medical devices · Type II
- RENASYS EZ NEGATIVE PRESSURE WOUND THERAPY (2015-02-02)April 2, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.