3nethra
The 3nethra neo P1000 is a mydriatic digital imaging camera used for capturing and storing images of the human retina. The device acquires only digital photographs of the eye and does not…
The 3nethra neo P1000 is a mydriatic digital imaging camera used for capturing and storing images of the human retina. The device acquires only digital photographs of the eye and does not provide any analysis or diagnosis. The 3nethra neo has a hand-held probe, a control unit, and a foot pedal. Components such as warm white LEDs, lenses, aperture, sensitive photodetector arrays (CMOS sensor array) are housed in the probe. The light emitted is within the safe limits of group 1 radiant exposure specifications for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the 15004-2 (and ANSI Z80.36-2016) Light Hazard Protection standards for Ophthalmic Instruments. 3nethra neo includes an application software that facilitates the capture, storage, and retrieval of images. Illumination and focus are adjusted using a foot pedal.
Who Else Makes It
Concentrated in Chongqing (5), Jiangsu (3), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Main Meditech Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Chongqing SS Medical Equipments Co., Ltd. | Chongqing | Chongqing | Manufacturer | 3 |
| Chongqing BIO Newvision Medical Equipment Ltd. | Chongqing | Chongqing | Manufacturer | 2 |
Showing 12 of 14. All 14 manufacturers in China registered for Camera, Ophthalmic, General-Use
Record
| Listed by | Forus Health Pvt.ltd.,, India |
|---|---|
| FDA product code | PJZ |
| Device type | Camera, Ophthalmic, General-Use |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-14 |
| Record revised | 2026-05-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Classic camera | In distribution | |
| classic camera | In distribution | |
| pico | In distribution | |
| classic HD camera | In distribution | |
| classic HD stand | In distribution | |
| neo P1000 control box | In distribution | |
| classic stand | In distribution | |
| Stand | In distribution | |
| neo probe | In distribution | |
| neo P1000 probe | In distribution | |
| neo control box | In distribution | |
| classic 6.4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 12 |
| Welch Allyn | Medimaging Integrated Solution Inc. | 6 |
| Fundus Camera | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 6 |
| D-EYE | D-EYE SRL | 4 |
| Microclear | Suzhou Microclear Medical Instruments Co., Ltd. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| EyeCaster | Innovations Lightx Inc | 3 |
| Paxos Scope | Digisight Technologies, Inc. | 3 |
| Remidio | Remidio Innovative Solutions Inc | 3 |
| Volk Viva | Volk Optical Inc. | 2 |
| Volk VistaView | Volk Optical Inc. | 2 |
| PanoCam™ PRO | Visunex Medical Systems Inc. | 2 |
Showing 12 of 48. All products under Camera, Ophthalmic, General-Use
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.