Medical device licence · 83109 · Class 3
OMNILAB ADVANCED +
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83109
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- June 22, 2010
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OMNILAB ADVANCED + INTERNATIONAL
- OMNILAB ADVANCED + INTERNATIONAL WITH HEATED TUBE HUMIDIFIER
- OMNILAB ADVANCED + INTERNATIONAL WITH HUMIDIFIER
- OMNILAB ADVANCED + WITH HEATED TUBE HUMIDIFIER, DOMESTIC
- OMNILAB ADVANCED+ W/ HUM, DOMESTIC
- OMNILAB ADVANCED+, DOMESTIC
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 “omnilab”. A notice may cover another product or only some lots: read it to see what it covers.
- Omnilab Advanced Domestic and Omnilab Advanced Domestic CoreMay 15, 2024 · Anaesthesiology · Performance · Type I
- Omnilab Advanced and BiPAP A40August 31, 2022 · Anaesthesiology · Performance · Type II
- OMNILAB V.12.0 - Laboratory Information System (Cytology-Pathology) (2019-01-15)March 22, 2019 · Medical devices · Medical devices · Type II
- OmniLab V.12.0 - Laboratory Information SystemMay 2, 2017 · Medical devices · Medical devices · Type II
- OmniLab V.12.0 - Laboratory Information SystemFebruary 28, 2017 · Medical devices · Type II
- OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM (2016-08-11)August 26, 2016 · Medical devices · Medical devices · Type II
- Omnilab Version 12 (2014-03-06)April 4, 2014 · 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.