Data / Medical devices / Corneal Inlay Inserter Handle
Corneal Inlay Inserter Handle (QGJ): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Corneal Inlay Inserter Handle (product code QGJ, Class 1, 21 CFR 886.4355). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QGJ
- Device class
- 1
- Regulation
- 886.4355
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| China | 2 |
| United Kingdom | 1 |
Makers of Corneal Inlay Inserter Handle
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 |
|---|---|---|---|---|---|---|---|---|
| Beaver-Visitec International, Ltd | BIDFORD-ON-AVON Warwickshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belle Healthcare Technology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Malosa Medical Instruments (Changshu) Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.