FDA device listing
Bellavar,Custom Seamless Soft
FDA device listing 1098411197 · BSN medical GmbH
Key facts
| Proprietary names | Bellavar,Custom Seamless Soft |
|---|---|
| Owner/operator | BSN medical GmbH |
| Owner/operator number | 9047426 |
| Premarket submissions | K131496 |
| Product codes | DWL |
| Device names | DWL - Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5780 |
| Review panels | General Hospital |
| Registered establishments | BSN-JOBST GMBH, Essity Distribution B.V. |
| Establishment registrations | 8043565, 3017633586 |
| FEI numbers | 3005588760, 3017633586 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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