FDA device listing
Hyravue,Ote MPS 045 MultiPurpose Solution
FDA device listing 1126127013 · OTE PHARMA SOL bv
Key facts
| Proprietary names | Hyravue,Ote MPS 045 MultiPurpose Solution |
|---|---|
| Owner/operator | OTE PHARMA SOL bv |
| Owner/operator number | 9106180 |
| Product codes | LPN |
| Device names | LPN - Accessories, Soft Lens Products |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.5928 |
| Review panels | Ophthalmic |
| Registered establishments | OTE PHARMA SOL bv |
| Establishment registrations | 3003485793 |
| FEI numbers | 3003485793 |
| Establishment operations | Contract 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