Medical device licence · 107512 · Class 2
VOLARA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 14, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107512
- Licence holder
- Hill-Rom Services Private LimitedSingapore, Singapore
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 14, 2022
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VOLARA SYSTEM
- VOLARA SYSTEM SINGLE PATIENT USE CIRCUIT
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 “volara”. A notice may cover another product or only some lots: read it to see what it covers.
- Volara System Patient CiruitMay 29, 2026 · Anaesthesiology · Performance · Type II
- Volara System Single Patient Use CircuitJuly 2, 2024 · Anaesthesiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.