FDA device listing
Focus Acrylic,Focus Acrylic eclipse,Matrix Acrylic,Matrix Acrylic Aurium,Medennium Phakic Lens (MPL)
FDA device listing 1375766319 · MEDENNIUM, INC.
Key facts
| Proprietary names | Focus Acrylic,Focus Acrylic eclipse,Matrix Acrylic,Matrix Acrylic Aurium,Medennium Phakic Lens (MPL) |
|---|---|
| Owner/operator | MEDENNIUM, INC. |
| Owner/operator number | 9040473 |
| Product codes | HQL |
| Device names | HQL - Intraocular Lens |
| Device class | Class III |
| Classification regulations (21 CFR) | 886.3600 |
| Review panels | Ophthalmic |
| Registered establishments | MEDENNIUM, INC. |
| Establishment registrations | 2031959 |
| FEI numbers | 3002777043 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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