FDA device listing
Biofinity,Biofinity Energys,BIOFINITY MULTIFOCAL,BIOFINITY TORIC,BIOFINITY TORIC MULTIFOCAL,BIOFINITY XR,Biofinity XR…
FDA device listing 1785821755 · COOPERVISION, INC.
Key facts
| Proprietary names | Biofinity,Biofinity Energys,BIOFINITY MULTIFOCAL,BIOFINITY TORIC,BIOFINITY TORIC MULTIFOCAL,BIOFINITY XR,Biofinity XR Multifocal,Biofinity XR Toric |
|---|---|
| Owner/operator | COOPERVISION, INC. |
| Owner/operator number | 9929062 |
| Premarket submissions | P080011 |
| Product codes | LPM |
| Device names | LPM - Lenses, Soft Contact, Extended Wear |
| Device class | Class III |
| Classification regulations (21 CFR) | 886.5925 |
| Review panels | Ophthalmic |
| Registered establishments | CooperVision, Inc., COOPERVISION INC., COOPERVISION, INC., CooperVision Manufacturing Ltd, CooperVision Manufacturing, LTD., COOPERVISION MANUFACTURING, LTD., COOPERVISION Manufacturing Puerto Rico, LLC |
| Establishment registrations | 1314956, 2640128, 9614392, 3005724763, 3006514242, 3008586477, 3011771819 |
| FEI numbers | 1314956, 3002806417, 3002911336, 3005724763, 3006514242, 3008586477, 3011771819 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes 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