3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic…
3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Chongqing (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for 3nethra | Listed by | Forus Health Pvt.ltd.,, India |
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K243600 |
| Record published | 2026-06-30 |
| Record revised | 2026-05-29 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.