Not currently registered with FDA under this name
Biom'Up Sas
St-Priest, France. Named as applicant on 1 dental 510(k) clearance between 2011 and 2011. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12011–2011
- Markets registered in
- 68 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Biom'Up Sas as the manufacturer or the registration holder of a device.
RegisteredHome: FranceOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Biom'Up Sas | 1 clearances | 2011–2011 | Below |
| Colombia | INVIMA | Manufacturer | BIOMUP S.A.BIOM`UP S.A. | 3 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BIOM'UP SA | 2 | 2013–2014 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | BIOM UP | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Biom'Up | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Biom’Up | 1 | 2014–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.