Medical device licence · 113296 · Class 2
FLUXMED
Yes: licensed in Canada
Licence status Issued (active); first licensed May 12, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113296
- Licence holder
- Fisbol International S.A.Montevideo, UY
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 12, 2025
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT FLOW SENSOR
- CAPNOGRAPHY MODULE
- CO2 ADULT AIRWAY ADAPTER (DISPOSABLE)
- CO2 ADULT AIRWAY ADAPTER (REUSABLE)
- CO2 NEONATAL AIRWAY ADAPTER (DISPOSABLE)
- CO2 NEONATAL AIRWAY ADAPTER (REUSABLE)
- DOUBLE BALLOON FOR ESOPHAGEAL AND GASTRIC PRESSURE MEASUREMENT
- EIT CONNECTION CABLE
- EIT ELECTRODE STRAP
- EIT MODULE
- EIT PATIENT CABLE
- EXTENSION
- EXTENSION WITH 3-WAY STOPCOCK
- FLUXMED
- INTERFACE CABLE FOR CO2 MODULE (TYPE M)
- INTERFACE CABLE FOR CO2 MODULE (TYPE P)
- PRESSURE AND FEEDING PROBE WITH CONICAL CONNECTOR
- PRESSURE AND FEEDING PROBE WITH ENFIT CONNECTOR
- PRESSURE PROBE
- PRESSURE PROBE
- SPO2 FINGER CLIP SENSOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.