Medical device licence · 16579 · Class 3
ISOMED SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 31, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 16579
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 31, 2000
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CATHETER PASSER WITH OBTURATOR
- ISOMED CAP KIT
- ISOMED IMPLANTABLE FIXED RATE PUMP
- ISOMED REFILL KIT
- SYNCROMED SYSTEM - ALGOLINE CATHETER
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 “isomed”. A notice may cover another product or only some lots: read it to see what it covers.
- Isomed Refill Kit (2019-11-15)December 20, 2019 · 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.