FDA device listing
Stocking, Elastic
FDA device listing 1312209478 · Sigvaris Holding AG
Key facts
| Owner/operator | Sigvaris Holding AG |
|---|---|
| Owner/operator number | 8031005 |
| Product codes | ILG |
| Device names | ILG - Stocking, Elastic |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | SIGVARIS AG, Sigvaris Do Brasil Ind. E Com. LTDA, SIGVARIS, INC., SIGVARIS Inc. - Holland Facility |
| Establishment registrations | 1221770, 8031005, 3004903147, 3005550595 |
| FEI numbers | 5929, 1221770, 3004903147, 3005550595 |
| Establishment operations | Manufacturer, Repackager/Relabeler, 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