OptochekPlus
Catalogue number 15170, listed by Reichert Inc., United States, under Retinoscope, Ac-Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Reichert Inc., United States |
|---|---|
| FDA product code | HKL |
| Device type | Retinoscope, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1780 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15170 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 5 |
| 3.6V Specialist Ophth IN Case | Keeler Ltd. | 2 |
| 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 |
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.