FDA device listing
Penguin RFA
FDA device listing 1180693196 · HANSAMED LIMITED dba CITAGENIX
Key facts
| Proprietary names | Penguin RFA |
|---|---|
| Owner/operator | HANSAMED LIMITED dba CITAGENIX |
| Owner/operator number | 9076685 |
| Premarket submissions | K143445 |
| Product codes | EKX |
| Device names | EKX - Handpiece, Direct Drive, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | HANSAmed Limited DBA Citagenix |
| Establishment registrations | 3004431266 |
| FEI numbers | 3004431266 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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