Data / Medical devices / Ireland / Incereb Ltd
Incereb Ltd: FDA-registered device maker in Dublin Dun Laoghaire-Rathdown, Ireland, 1 510(k) clearance
Incereb Ltd is registered with the FDA (registration 3004695199) in Dublin Dun Laoghaire-Rathdown, Ireland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004695199
- Address
- 6 Charlemont Terrace Crofton Road, Dun Laoghaire, Dublin Dun Laoghaire-Rathdown, Ireland, A96 F8W5
- Owner or operator
- Incereb Ltd (10051067)
- Roles
- Manufacturer
- First device listed
- February 1, 2016
- Registered through
- 2026
- Brand names listed
- NEON EEG, Neon10, Neon10 NeuroBell, Neon12 KIT, Neon8 KIT, neon12, neon6, neon8
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 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 |
|---|---|---|---|---|---|---|
| September 29, 2015 | K151576 | Neon EEG | GXY | Substantially Equivalent | Incereb, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 29, 2015. 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.