Remidio
Anterior Imaging Module (AIM) is intended for screening, capture and storage of images of the Anterior part of eye and surrounding area, AIM camera is designed to be attached to any…
Anterior Imaging Module (AIM) is intended for screening, capture and storage of images of the Anterior part of eye and surrounding area, AIM camera is designed to be attached to any existing 3 step or 5 step slit lamps for true colour and monochrome imaging in visible spectrum of light. The camera of a smart phone is used to capture images of the eye. The device can be used at any time & over & over again by a trained user.
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 | Remidio Innovative Solutions Inc, United States |
|---|---|
| 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 | 2020-02-19 |
| Record revised | 2023-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 700 to 1060 KiloPascal; Handling environment humidity 10 to 95 % RH; Handling environment temperature 0 to 40 °C; Storage environment temperature -10 to 55 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AIM | In distribution | |
| 001 | In distribution | |
| Remidio FOP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 12 |
| 3nethra | Forus Health Pvt.ltd., | 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 |
| 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.