FDA device listing
Confidence Be,Confidence Convex Supersoft,Confidence Natural,Confidence Natural Advance,Confidence Natural Soft…
FDA device listing 1403639990 · SALTS HEALTHCARE LIMITED
Key facts
| Proprietary names | Confidence Be,Confidence Convex Supersoft,Confidence Natural,Confidence Natural Advance,Confidence Natural Soft Convex,Harmony Duo,Second Nature |
|---|---|
| Owner/operator | SALTS HEALTHCARE LIMITED |
| Owner/operator number | 9019444 |
| Product codes | FON |
| Device names | FON - Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | SALTS HEALTHCARE LIMITED |
| Establishment registrations | 9617198 |
| FEI numbers | 3006402425 |
| 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