FDA device listing
Gold Cross,GSTC,Heuer
FDA device listing 1483713557 · GST CORPORATION LIMITED
Key facts
| Proprietary names | Gold Cross,GSTC,Heuer |
|---|---|
| Owner/operator | GST CORPORATION LIMITED |
| Owner/operator number | 9075660 |
| Product codes | EXH |
| Device names | EXH - Bag, Urinary, Ileostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Heuer International (A division of GST Corporation Limited) |
| Establishment registrations | 3005273623 |
| FEI numbers | 3005273623 |
| Establishment operations | Foreign Private Label Distributor, 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