Data / Medical devices / France / Azmed SAS
Azmed SAS: FDA-registered device maker in Paris, France, 3 510(k) clearances
Azmed SAS is registered with the FDA (registration 3026753394) in Paris, France. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 28, 2026. 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
- 3026753394
- Address
- 10 Rue D'Uzes, Paris, France, 75002
- Owner or operator
- AZmed (10087096)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 15, 2026
- Registered through
- 2026
- Brand names listed
- Rayvolve, Rayvolve AZchest, Rayvolve LN
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Fracture | QBS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 28, 2026 | K261378 | Rayvolve AZchest | QBS | Substantially Equivalent | AZmed | accessdata.fda.gov |
| May 12, 2026 | K260378 | Rayvolve | QBS | Substantially Equivalent | AZmed | accessdata.fda.gov |
| March 26, 2025 | K243831 | Rayvolve LN | MYN | Substantially Equivalent | AZmed | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- All makers of Analyzer, Medical Image
Updated August 28, 2026. 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.