Data / Medical devices / Lens, Fundus, Hruby, Diagnostic
Lens, Fundus, Hruby, Diagnostic (HJI): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Lens, Fundus, Hruby, Diagnostic (product code HJI, Class 1, 21 CFR 886.1395). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on November 16, 1992, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- HJI
- Device class
- 1
- Regulation
- 886.1395
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| Switzerland | 2 |
| India | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
Makers of Lens, Fundus, Hruby, Diagnostic
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 |
|---|---|---|---|---|---|---|---|---|
| Alcon Grieshaber AG | Neuhausen Schaffhausen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Grieshaber AG | Schaffhausen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Ophthalmic Instruments FZE | Dubai Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RUMEX Baltics SIA | Riga, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 16, 1992. 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.