Data / Medical devices / Poland / Enbio Technology SP. Z.O.O.
Enbio Technology SP. Z.O.O.: FDA-registered device maker in Gdynia Pomorskie, Poland, 1 510(k) clearance
Enbio Technology SP. Z.O.O. is registered with the FDA (registration 3018815412) in Gdynia Pomorskie, Poland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 26, 2026. Registered through 2027. 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
- 3018815412
- Address
- Polnocna 10 Street, Gdynia Pomorskie, Poland, PL-81-029
- Owner or operator
- Enbio Technology Sp. z.o.o. (10084687)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 22, 2022
- Registered through
- 2027
- Brand names listed
- Enbio PRO, Enbio S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 2 | Contract manufacturer, 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 |
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.