Data / Medical devices / Hungary / Zeto EU Kft.
Zeto EU Kft.: FDA-registered device maker in Szeged, Hungary, 3 510(k) clearances
Zeto EU Kft. is registered with the FDA (registration 3017970307) in Szeged, Hungary. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017970307
- Address
- Zoltan Utca 6, Szeged, Hungary, 6724
- Owner or operator
- Zeto, Inc. (10057738)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- May 20, 2018
- Registered through
- 2026
- Brand names listed
- New Wave, WR19, Zeto ONE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 13, 2026 | K260455 | New Wave System | GWQ | Substantially Equivalent | Zeto, Inc. | accessdata.fda.gov |
| April 30, 2024 | K233403 | Flexset System | GWQ | Substantially Equivalent | Zeto, Inc. | accessdata.fda.gov |
| April 17, 2018 | K172735 | WR19 System | GWQ | Substantially Equivalent | Zeto, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 13, 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.