FDA device listing
Poise & Depends,SPEAX, Thinx For All Leaks
FDA device listing 1530501883 · Unichela Pvt Ltd - Panadura
Key facts
| Proprietary names | Poise & Depends,SPEAX, Thinx For All Leaks |
|---|---|
| Owner/operator | Unichela Pvt Ltd - Panadura |
| Owner/operator number | 10085203 |
| Product codes | EYQ |
| Device names | EYQ - Garment, Protective, For Incontinence |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5920 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | UNICHELA PVT LTD - PANADURA |
| Establishment registrations | 3017202440 |
| FEI numbers | 3017202440 |
| Establishment operations | Contract 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