Data / Medical devices / France / Qualiformed SAS
Qualiformed SAS: FDA-registered device maker in La Roche Sur Yon Pays de la Loire, France, 1 510(k) clearance
Qualiformed SAS is registered with the FDA (registration 3009607881) in La Roche Sur Yon Pays de la Loire, France. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009607881
- Address
- 19 impasse de La Boetie, La Roche Sur Yon Pays de la Loire, France, 85000
- Owner or operator
- QualiFormeD SAS (10040700)
- Roles
- Manufacturer
- First device listed
- May 9, 2012
- Registered through
- 2026
- Brand names listed
- DIGIBOX, DIGIPHAN, FIELD-TAPE, LINACWATCH, MAGICTAPE, OTP-ABACUS-CL, OTP-ABACUS-EL, OTP-ALIGN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Radiographic | IXG | 1 | Manufacturer | accessdata.fda.gov |
| Test-Pattern, Radiographic | IXF | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2017 | K172534 | LINACwatch, LinacView | IYE | Substantially Equivalent | Qualiformed Sarl | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Phantom, Anthropomorphic, Radiographic
- All makers of Test-Pattern, Radiographic
- All makers of Accelerator, Linear, Medical
Updated October 27, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.