Data / Medical devices / Belgium / Medisoft S.A.
Medisoft S.A.: FDA-registered device maker in DINANT Namur, Belgium, 4 510(k) clearances
Medisoft S.A. is registered with the FDA (registration 3003630525) in DINANT Namur, Belgium. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003630525
- Address
- Rue du Clairon 5, DINANT Namur, Belgium, 5503
- Owner or operator
- MEDISOFT S.A. (9049133)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 15, 2008
- Registered through
- 2026
- Brand names listed
- Body Box, Fenom Pro, SpiroAir, TransAir2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Pulmonary Function Data | BZC | 2 | Manufacturer | accessdata.fda.gov |
| Plethysmograph, Volume | JEH | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Breath Nitric Oxide | MXA | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| June 7, 2023 | K213611 | Fenom Pro | MXA | Substantially Equivalent | Caire Diagnostics, Inc. | accessdata.fda.gov |
| May 4, 2005 | K042595 | SPIRO'AIR | BZG | Substantially Equivalent | Morgan Scientific, Inc. | accessdata.fda.gov |
| January 13, 2003 | K022636 | BODY BOX 5500 | JEH | Substantially Equivalent | Morgan Scientific, Inc. | accessdata.fda.gov |
| December 9, 1996 | K953990 | TRANSFLOW TEST | BZC | Substantially Equivalent | P.K. Morgan , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Spirometer, Diagnostic
- All makers of Plethysmograph, Volume
- All makers of System, Test, Breath Nitric Oxide
- All makers of Calculator, Pulmonary Function Data
Updated June 7, 2023. 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.