Data / Medical devices / Ireland / Neurent Medical Ltd
Neurent Medical Ltd: FDA-registered device maker in Galway Galway(County), Ireland, 3 510(k) clearances
Neurent Medical Ltd is registered with the FDA (registration 3016813690) in Galway Galway(County), Ireland. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016813690
- Address
- Office Unit 8c, Oran Point, Main Street Oranmore, Galway Galway(County), Ireland, H91 K6WF
- Owner or operator
- Neurent Medical Limited (10083199)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 16, 2022
- Registered through
- 2027
- Brand names listed
- NEUROMARK System, Neuromark System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 16, 2026 | K261833 | NEUROMARK System (NMK00301) | GEI | Substantially Equivalent | Neurent Medical , Ltd. | accessdata.fda.gov |
| May 29, 2025 | K250048 | NEUROMARK System (NMK00301) | GEI | Substantially Equivalent | Neurent Medical , Ltd. | accessdata.fda.gov |
| October 26, 2022 | K222032 | NEUROMARK System | GEI | Substantially Equivalent | Neurent Medical | accessdata.fda.gov |
Compare with other makers
Updated June 16, 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.