FDA device listing
Unit, Phacofragmentation
FDA device listing 1981353237 · Medistri SA
Key facts
| Owner/operator | Medistri SA |
|---|---|
| Owner/operator number | 10024700 |
| Product codes | HQC, HQE |
| Device names | HQC - Unit, Phacofragmentation, HQE - Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.4150, 886.4670 |
| Review panels | Ophthalmic |
| Registered establishments | MEDISTRI SA |
| Establishment registrations | 3006946276 |
| FEI numbers | 3006946276 |
| Establishment operations | Contract Sterilizer |
| 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