FDA device listing
absente 01-gold,absente 01-gunmetal,absente 01(M)-gold,absente 01(M)-gunmetal,absente 03-gold,absente…
FDA device listing 1051333121 · IICOMBINED CO., LTD.
Key facts
| Proprietary names | absente 01-gold,absente 01-gunmetal,absente 01(M)-gold,absente 01(M)-gunmetal,absente 03-gold,absente 03-gunmetal,absente C1(M)-gold,absente C1(M)-gunmetal,absente GD3(M)-gold,absente GD3(M)-gunmetal,absente PD1-gold,absente PD1-gunmetal,absente PD1(M)-gold,absente PD1(M)-gunmetal,absente PD4(M)-gold,absente PD4(M)-gunmetal,Absent one,absolute 2 01,absolute 2 01(M),absolute 2 B4,absolute 2… |
|---|---|
| Owner/operator | IICOMBINED CO., LTD. |
| Owner/operator number | 10042464 |
| 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 | IICOMBINED Co., Ltd. |
| Establishment registrations | 3009789566 |
| FEI numbers | 3009789566 |
| 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