FDA device listing
Eyeglass Frame,Finished Lenses,magnifying,Ophthalmic lenses,UV blockers glasses
FDA device listing 1723799481 · ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD
Key facts
| Proprietary names | Eyeglass Frame,Finished Lenses,magnifying,Ophthalmic lenses,UV blockers glasses |
|---|---|
| Owner/operator | ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD |
| Owner/operator number | 10079968 |
| Product codes | NJH |
| Device names | NJH - Lens, Spectacle (Prescription), For Reading Discomfort |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.5844 |
| Review panels | Ophthalmic |
| Registered establishments | ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD |
| Establishment registrations | 3017965799 |
| FEI numbers | 3017965799 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database