Flosonics Medical (R/A 1929803 Ontario Corp.)
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000001254 FEI 3015139886
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Advena LimitedMT
Catalogue
- Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- CA-MF-000001254
- FDA FEI number
- 3015139886
- EUDAMED status
- Active
- EUDAMED registered name
- Flosonics Medical (R/A 1929803 Ontario Corp.)
- Registered address
- 325, FRONT STREET WEST, M5V2Y1, TORONTO, Canada
- [email protected]
- PRRC contact
- Wen Tan
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 7 Aug 2025 Z-2517-2025 Class III Ongoing Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
Frequently asked questions
How many devices does Flosonics Medical (R/A 1929803 Ontario Corp.) have in the registry?
The registry currently lists 1 device for Flosonics Medical (R/A 1929803 Ontario Corp.). Devices recorded under merged duplicate company entries are counted once.
Which registries list Flosonics Medical (R/A 1929803 Ontario Corp.)'s devices?
Among its 1 most recently registered device, Flosonics Medical (R/A 1929803 Ontario Corp.) has devices listed in EUDAMED (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Flosonics Medical (R/A 1929803 Ontario Corp.)'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Flosonics Medical (R/A 1929803 Ontario Corp.)'s devices are Class IIa. Each device page shows its own class and authorisation.
Are there FDA recall records for Flosonics Medical (R/A 1929803 Ontario Corp.)?
FDA recall records list 1 recall initiated by Flosonics Medical (R/A 1929803 Ontario Corp.), the most recent initiated on 7 Aug 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Flosonics Medical (R/A 1929803 Ontario Corp.) in the registry?
The most recently registered devices listed for Flosonics Medical (R/A 1929803 Ontario Corp.) include FloPatch FP120.