FDA device listing
Ambu aBox 2,Ambu aScope Duodeno 2
FDA device listing 1587064143 · AMBU A/S
Key facts
| Proprietary names | Ambu aBox 2,Ambu aScope Duodeno 2 |
|---|---|
| Owner/operator | AMBU A/S |
| Owner/operator number | 8010067 |
| Premarket submissions | K233886 |
| Product codes | FDT, FET |
| Device names | FDT - Duodenoscope And Accessories, Flexible/Rigid, FET - Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Ambu A/S, AMBU SDN.BHD. |
| Establishment registrations | 9610691, 3004040397 |
| FEI numbers | 3002806359, 3004040397 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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