Data / Medical devices / Germany / Localite GMBH
Localite GMBH: FDA-registered device maker in Bonn North Rhine-Westphalia, Germany, 1 510(k) clearance
Localite GMBH is registered with the FDA (registration 3017603615) in Bonn North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017603615
- Address
- Auguststr. 1, Bonn North Rhine-Westphalia, Germany, 53229
- Owner or operator
- Localite GmbH (10082964)
- Roles
- Manufacturer
- First device listed
- May 24, 2023
- Registered through
- 2026
- Brand names listed
- Localite TMS Navigator TS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | 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 |
|---|---|---|---|---|---|---|
| April 17, 2023 | K223577 | Localite TMS Navigator TS | HAW | Substantially Equivalent | Localite GmbH | accessdata.fda.gov |
Compare with other makers
Updated April 17, 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.