Data / Medical devices / France / Apelem
Apelem: FDA-registered device maker in Gallargues-le-Montueux Gard, France, 1 510(k) clearance
Apelem is registered with the FDA (registration 9616491) in Gallargues-le-Montueux Gard, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616491
- FEI number
- 3000255482
- Address
- 9 Avenue du Canal Philippe LAMOUR, Gallargues-le-Montueux Gard, France, 30660
- Owner or operator
- Apelem (10047281)
- Roles
- Manufacturer
- First device listed
- January 26, 2021
- Registered through
- 2026
- Brand names listed
- DRX EXCEL Plus, FDX Visionary-RF PREMIUM, PLATINUM dRF, Persona RF PREMIUM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | 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 |
|---|---|---|---|---|---|---|
| January 22, 2021 | K203010 | Platinum dRF Imaging System | JAA | Substantially Equivalent | Apelem-Dms Group | accessdata.fda.gov |
Compare with other makers
Updated January 22, 2021. 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.