FDA device listing
Dolfino
FDA device listing 1203563831 · AQUA LEISURE RECREATION LLC
Key facts
| Proprietary names | Dolfino |
|---|---|
| Owner/operator | AQUA LEISURE RECREATION LLC |
| Owner/operator number | 1221480 |
| Product codes | HQY |
| Device names | HQY - Sunglasses (Non-Prescription Including Photosensitive) |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.5850 |
| Review panels | Ophthalmic |
| Registered establishments | GREYLAND TRADING LTD, KWIK TEK, INC., TOPWAY SPORTS ENTERPRISE CO LTD, XINGCHEN ARTS & CRAFTS SDN.BHD. |
| Establishment registrations | 3000159466, 3001551265, 3027307208, 3040312681 |
| FEI numbers | 3000159466, 3001551265, 3027307208, 3040312681 |
| Establishment operations | Contract Manufacturer, 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