FDA device listing
LED 100 Double Dome, LED 100 Triple Dome; LED 150 Single Dome, LED 150 Double Dome, LED 150 Triple Dome,LED 50 Single…
FDA device listing 1116063874 · HOSPEDIA MEDICARE PVT LTD
Key facts
| Proprietary names | LED 100 Double Dome, LED 100 Triple Dome; LED 150 Single Dome, LED 150 Double Dome, LED 150 Triple Dome,LED 50 Single Dome; LED 50 Double Dome; LED 50 Triple Dome; LED 100 Single Dome,PRECISION 100 Single Dome, PRECISION 100 Double Dome, PRECISION 100 Triple Dome,PRECISION 300 Single DomePRECISION 300 Double Dome, PRECISION 300 Triple Dome |
|---|---|
| Owner/operator | HOSPEDIA MEDICARE PVT LTD |
| Owner/operator number | 10080347 |
| Product codes | FSY |
| Device names | FSY - Light, Surgical, Ceiling Mounted |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4580 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HOSPEDIA MEDICARE PVT LTD |
| Establishment registrations | 3017970309 |
| FEI numbers | 3017970309 |
| 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