FDA device listing
Gastroenterology Urology Probe and Director
FDA device listing 1022641686 · Hexamed Pvt Ltd
Key facts
| Proprietary names | Gastroenterology Urology Probe and Director |
|---|---|
| Owner/operator | Hexamed Pvt Ltd |
| Owner/operator number | 10095463 |
| Product codes | FGM |
| Device names | FGM - Probe And Director, Gastro-Urology |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.4730 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | HEXAMED PVT LTD |
| Establishment registrations | 3032747418 |
| FEI numbers | 3032747418 |
| Establishment operations | Contract Manufacturer, 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