Kowa Nonmyd 8s
The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic.
14manufacturers in China registered for this device type
1catalogue number
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 | Kowa Co., Ltd., Japan |
|---|---|
| FDA product code | PJZ |
| Device type | Camera, Ophthalmic, General-Use |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 95 % RH; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 90 % RH |
| Sizes | Height 548 mm; depth 504 mm; width 310 mm; weight 21 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K9L63K | Height 548 mm | 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 |
| Remidio | Remidio Innovative Solutions Inc | 3 |
| Volk Viva | Volk Optical Inc. | 2 |
| Volk VistaView | Volk Optical 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.