Data / Medical devices / Switzerland / Enbio Group AG
Enbio Group AG: FDA-registered device maker in Oensingen Solothurn, Switzerland, 3 510(k) clearances
Enbio Group AG is registered with the FDA (registration 3016777357) in Oensingen Solothurn, Switzerland. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016777357
- Address
- Eichengasse 3, Oensingen Solothurn, Switzerland, 4702
- Owner or operator
- Enbio Group AG (10073617)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 12, 2020
- Registered through
- 2027
- Brand names listed
- Enbio PRO, Enbio S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| February 26, 2026 | K260254 | Enbio PRO | FLE | Substantially Equivalent | Enbio Group AG | accessdata.fda.gov |
| February 22, 2022 | K213991 | Enbio S | FLE | Substantially Equivalent | Enbio Group AG | accessdata.fda.gov |
| October 29, 2021 | K210279 | Enbio S | FLE | Substantially Equivalent | Enbio Group AG | accessdata.fda.gov |
Compare with other makers
Updated February 26, 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.