FDA device listing
Visualization system 4K-Light Cable,Visualization system 4K - Light Source
FDA device listing 1485801395 · HEALTHIUM MEDTECH LIMITED
Key facts
| Proprietary names | Visualization system 4K-Light Cable,Visualization system 4K - Light Source |
|---|---|
| Owner/operator | HEALTHIUM MEDTECH LIMITED |
| Owner/operator number | 9064005 |
| Product codes | FCR |
| Device names | FCR - Light Source, Photographic, Fiberoptic |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | HEALTHIUM MEDTECH LIMITED |
| Establishment registrations | 3004944585 |
| FEI numbers | 3004944585 |
| Establishment operations | 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