Data / Medical devices / Reader, Prism, Ophthalmic
Reader, Prism, Ophthalmic (HJX): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Reader, Prism, Ophthalmic (product code HJX, Class 1, 21 CFR 886.5810). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 9, 2000, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HJX
- Device class
- 1
- Regulation
- 886.5810
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| China | 2 |
| India | 1 |
| Vietnam | 1 |
Makers of Reader, Prism, Ophthalmic
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 |
|---|---|---|---|---|---|---|---|---|
| Dahong Optical (xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Ouhai Glasses Co., Ltd. | Bac Ninh Province, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Zhi Cheng Optical Co.ltd | OUHAI, WENZHOU Zhejiang, China | Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 9, 2000. 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.