FDA device listing
Prescription Lens
FDA device listing 1704582399 · Wenzhou Tide-Optical Co., Ltd.
Key facts
| Proprietary names | Prescription Lens |
|---|---|
| Owner/operator | Wenzhou Tide-Optical Co., Ltd. |
| Owner/operator number | 10086309 |
| 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 | Wenzhou Tide-Optical Co., Ltd. |
| Establishment registrations | 3023152124 |
| FEI numbers | 3023152124 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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