FDA device listing
Alphonso Paediatric Speculum,Barraquer Speculum,Barraquer Speculum, Flat Blade,Barraquer Speculum, Solid Blade…
FDA device listing 1369932632 · Beaver-Visitec International, Inc.
Key facts
| Proprietary names | Alphonso Paediatric Speculum,Barraquer Speculum,Barraquer Speculum, Flat Blade,Barraquer Speculum, Solid Blade (PC),Barrett Speculum,Clarke Speculum,Cook Neonatal Speculum,Corcelle Speculum Solid Blade,Infant Speculum,IOL Manipulator, Jaffe - Maltzman, Blunt tip 45 degree,Kratz-Barraquer,Kratz-Barraquer Speculum,Kratz-Barraquer Speculum, Curved,Kratz-Barraquer Speculum, Temporal,Mechanical… |
|---|---|
| Owner/operator | Beaver-Visitec International, Inc. |
| Owner/operator number | 10033379 |
| Product codes | HNC |
| Device names | HNC - Specula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | Beaver-Visitec International, Inc., Beaver-Visitec International, Ltd, Grupo American Industries, S.A. de C.V, Malosa Medical Instruments (Changshu) Limited |
| Establishment registrations | 1211998, 9680620, 3012733432, 3013421458, 3013466775 |
| FEI numbers | 1211998, 3002808441, 3012733432, 3013421458, 3013466775 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| 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