Kowa Nonmyd 8
The KOWA nonmyd 8 is intended for use with retinal image capturing without mydriatic.
3manufacturers in China registered for this device type
1catalogue number
14510(k) clearances naming this product code
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Chongqing BIO Newvision Medical Equipment Ltd. | Chongqing | Chongqing | Manufacturer | 2 |
Record
| Listed by | Kowa Co., Ltd., Japan |
|---|---|
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Record published | 2016-09-16 |
| Record revised | 2026-04-21 (version 3) |
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 | Width 310 mm; depth 504 mm; height 548 mm; weight 21 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K9L61K | Width 310 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 15 |
| Neolight | Neolight, LLC | 11 |
| Natus | Xltek | 6 |
| RetCam Envision | Natus Medical Denmark ApS | 6 |
| 3nethra | Forus Health Pvt.ltd., | 6 |
| iCam | Optovue, Inc. | 5 |
| iFusion | Optovue, Inc. | 5 |
| Canon Inc. | Canon Inc. | 4 |
| Camera, Ophthalmic, Ac-Powered | Chongqing Kanghuaruiming S&T Co., Ltd.. | 4 |
| 3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2) | Topcon Corp. | 3 |
| Retinal Camera TRC-50DX | Topcon Corp. | 3 |
| NON-Mydriatic Retinal Camera TRC-NW400 | Topcon Corp. | 2 |
Showing 12 of 123. All products under Camera, Ophthalmic, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191945 | 2019-09-10 |
| K190573 | 2019-06-04 |
| K112330 | 2012-02-16 |
| K101628 | 2011-01-26 |
| K091098 | 2009-08-07 |
| K091683 | 2009-07-02 |
| K083387 | 2009-01-16 |
| K082767 | 2008-10-21 |
| K080681 | 2008-04-04 |
| K062021 | 2006-11-01 |
| K062356 | 2006-09-27 |
| K053026 | 2005-11-10 |
| K050271 | 2005-11-03 |
| K043213 | 2005-10-06 |
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.