FDA device listing
pentax A120251 DSU EB 1970K No 62 and pentax G120362 DSU EB 1970K
FDA device listing 1475993474 · Medical Resale PTY Limited
Key facts
| Proprietary names | pentax A120251 DSU EB 1970K No 62 and pentax G120362 DSU EB 1970K |
|---|---|
| Owner/operator | Medical Resale PTY Limited |
| Owner/operator number | 10047901 |
| Premarket submissions | K131028 |
| Product codes | EOQ |
| Device names | EOQ - Bronchoscope (Flexible Or Rigid) |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4680 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Medical Resale PTY Limited |
| Establishment registrations | 3011416394 |
| FEI numbers | 3011416394 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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