3.6v Specialist Ophth IN Case
2 catalogue numbers from 1132-P-1157, listed by Keeler Ltd., United Kingdom, under Retinoscope, Ac-Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
Record
| Listed by | Keeler Ltd., United Kingdom |
|---|---|
| FDA product code | HKL |
| Device type | Retinoscope, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1780 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-08-26 |
| Record revised | 2023-12-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1132-P-1157 | In distribution | |
| 1132-P-1157-500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 5 |
| 3.6V Professional Ophth IN Case | Keeler Ltd. | 2 |
| 3.6V Streak RET & Prof Ophth | Keeler Ltd. | 1 |
| 3.6V Professional Streak Retinoscope IN Case | Keeler Ltd. | 1 |
| US Prof Student KIT (Slim Handle) | Keeler Ltd. | 1 |
| US LED Specialist/ Retinoscope Student SET | Keeler Ltd. | 1 |
| 3.6V Professional Streak LED Retinoscope IN Case | Keeler Ltd. | 1 |
| 2.8V Spot RET & Specialist Ophth | Keeler Ltd. | 1 |
| 3.6V Practitioner/ Fibre-Optic Diagnostic SET | Keeler Ltd. | 1 |
| US Professional Complete LED Student SET | Keeler Ltd. | 1 |
| 3.6V Professional Spot RET & Case | Keeler Ltd. | 1 |
| OptochekPlus | Reichert Inc. | 1 |
Showing 12 of 26. All products under Retinoscope, 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.