FDA device listing
Child Trial Frame,Lens Holder Handle,Lens Holder Kit 4 Well,Lens Holder Kit 8 Well,Lens Holder Nose Bridge,Lens Holder…
FDA device listing 1757140975 · GULDEN OPHTHALMICS INC
Key facts
| Proprietary names | Child Trial Frame,Lens Holder Handle,Lens Holder Kit 4 Well,Lens Holder Kit 8 Well,Lens Holder Nose Bridge,Lens Holder without Scale,Lens Holder with Scale,Pediatric Trial Frame,Premium Trial Frame,Raff Level Trial Flipper,Universal Lightweight Trial Frame,Universal Trial Frame |
|---|---|
| Owner/operator | GULDEN OPHTHALMICS INC |
| Owner/operator number | 2518410 |
| Product codes | HPA |
| Device names | HPA - Frame, Trial, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.1415 |
| Review panels | Ophthalmic |
| Registered establishments | GULDEN OPHTHALMICS |
| Establishment registrations | 2518410 |
| FEI numbers | 2518410 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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