FDA device listing
Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set,Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set
FDA device listing 1255922960 · AMBU A/S
Key facts
| Proprietary names | Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set,Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set |
|---|---|
| Owner/operator | AMBU A/S |
| Owner/operator number | 8010067 |
| Premarket submissions | K223782 |
| 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 | 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