McKesson
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7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Raish Meditech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Jiang XI BIG Vision Medical Technology Co., Ltd. | Ganzhou | Jiangxi | Manufacturer | 3 |
| Robotrak Technologies Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | HLI |
| Device type | Ophthalmoscope, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1570 |
| Premarket notification | Exempt |
| Record published | 2021-07-07 |
| Record revised | 2021-07-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 156-4PM3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 90 |
| Amico Diagnostic Station | Amico Diagnostic Incorporated | 55 |
| iVue | Optovue, Inc. | 27 |
| Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 19 |
| Amico Diagnostic Rollstand | Amico Diagnostic Incorporated | 14 |
| iScan | Optovue, Inc. | 7 |
| zumax | Zumax Medical Co., Ltd. | 6 |
| Jedmed | Jedmed Instrument Company | 3 |
| RTVue XR Avanti | Optovue, Inc. | 3 |
| Amico Diagnostic Ophthalmoscope | Amico Diagnostic Incorporated | 3 |
| Laser Speckle Flowgraphy Lsfg-Navi | Softcare Co., Ltd. | 2 |
| Panoramic Ophthalmoscope | Optos Public Limited Company | 1 |
Showing 12 of 46. All products under Ophthalmoscope, Ac-Powered
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.