Data / Medical devices / Retinoscope, Battery-Powered
Retinoscope, Battery-Powered (HKM): 16 FDA-registered makers in 6 countries
16 establishments in 6 countries are registered with the FDA to make Retinoscope, Battery-Powered (product code HKM, Class 1, 21 CFR 886.1780). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on January 9, 1997, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HKM
- Device class
- 1
- Regulation
- 886.1780
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 4 |
| Germany | 2 |
| India | 2 |
| Japan | 1 |
| Mexico | 1 |
Makers of Retinoscope, Battery-Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Rudolf Riester GMBH | JUNGINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | January 9, 1997 | 0 | 0 | 0 | api.fda.gov |
| 66 Vision Tech Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heine Optotechnik GMBH & Co. KG. | GILCHING Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | LIANYUNGANG Jiangsu, China | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neitz Instruments Company, Ltd. | CHIYODA-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ray Vision Inc. | Lake Forest, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Supore Instruments Co. Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiyuan North China Xinyuan Tech. Center (Co., LTD.) | TAIYUAN Shaanxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vision Research Corp. | Birmingham, AL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vision Training Products, Inc. | Mishawaka, IN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn De Mexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Zontai Int'l Corporation Ltd. | WUXI Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zumax Medical Co, Ltd. | Suzhou,Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 9, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.