FDA device listing
Dignity Complete Multiple Styles,Dignity Compose Multiple Styles,Dignity Extra Multiple Styles,Dignity, Multiple…
FDA device listing 1057032644 · PAUL HARTMANN AG
Key facts
| Proprietary names | Dignity Complete Multiple Styles,Dignity Compose Multiple Styles,Dignity Extra Multiple Styles,Dignity, Multiple Styles,Dignity Super Multiple Styles,Molicare Multiple Styles,Moliform Multiple Styles,Molimed Multiple Styles |
|---|---|
| Owner/operator | PAUL HARTMANN AG |
| Owner/operator number | 8010690 |
| 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 | PAUL HARTMANN AG, Paul Hartmann Iberia S.A., PAUL HARTMANN SAS |
| Establishment registrations | 8010690, 3002521238, 3003096716, 3003111059, 3004623655 |
| FEI numbers | 2926, 3002521238, 3003096716, 3003111059, 3004623655 |
| Establishment operations | Manufacturer, Specification Developer |
| 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