FDA device listing
AT04601 Abdominal Belt,AT04602 Abdominal Belt,AT04603 Abdominal Belt for Patients with stoma,AT04604 Abdominal Belt with…
FDA device listing 2011924888 · ANTAR Sp. J.
Key facts
| Proprietary names | AT04601 Abdominal Belt,AT04602 Abdominal Belt,AT04603 Abdominal Belt for Patients with stoma,AT04604 Abdominal Belt with Brace,AT04605 Abdominal Belt ULTRA BREATH |
|---|---|
| Owner/operator | ANTAR Sp. J. |
| Owner/operator number | 10060086 |
| Product codes | KTD |
| Device names | KTD - Orthosis, Abdominal |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | ANTAR SP. J. |
| Establishment registrations | 3015337148 |
| FEI numbers | 3015337148 |
| Establishment operations | 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