SpinaFX Medical Inc.
Active in EUDAMEDCanadafrom SRN EUDAMED SRN CA-MF-000040332
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Triojection 12mL Ref 918-012
Regimes: CE MDR Registry: EUDAMEDTriojection Console Ref 915-002
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CA-MF-000040332
- EUDAMED status
- Active
- EUDAMED registered name
- SpinaFX Medical Inc.
- EUDAMED abbreviated name
- SpinaFX
- Registered address
- 1920, Yonge St., M4S3E2, Toronto, Canada
- Website
- www.spinafx.com
- [email protected]
- Phone
- 1 866 323 9004
- PRRC contact
- John Soloninka
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 7 Jun 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 843778 Active
Quality management system EU MDR
- Issued
- 8 Jun 2026
- Expires
- 7 Jun 2031
From the company website
Discover the Triojection® System, an innovative ozone-based solution revolutionizing minimally invasive spine care. Explore our cutting-edge advancements.
Frequently asked questions
How many devices does SpinaFX Medical Inc. have in the registry?
The registry currently lists 2 devices for SpinaFX Medical Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SpinaFX Medical Inc.'s devices?
Among its 2 most recently registered devices, SpinaFX Medical Inc. has devices listed in EUDAMED (2 devices).
What risk classes do SpinaFX Medical Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for SpinaFX Medical Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SpinaFX Medical Inc.?
EUDAMED lists 1 certificate for SpinaFX Medical Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 8 Jun 2026.
What are the newest devices from SpinaFX Medical Inc. in the registry?
The most recently registered devices listed for SpinaFX Medical Inc. include Triojection 12mL and Triojection Console.