FDA device listing
Tecfen Iris Retractor
FDA device listing 1269189446 · TECFEN MEDICAL
Key facts
| Proprietary names | Tecfen Iris Retractor |
|---|---|
| Owner/operator | TECFEN MEDICAL |
| Owner/operator number | 10047971 |
| Product codes | HOC |
| Device names | HOC - Clip, Iris Retractor |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | TECFEN MEDICAL |
| Establishment registrations | 3010487482 |
| FEI numbers | 3010487482 |
| Establishment operations | Repackager/Relabeler |
| 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