Ambu A/S
DK-MF-000001437 · Denmark · Ballerup
Ambu A/S is registered in the European database on medical devices as a manufacturer, with 353 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 353 |
|---|
Most frequent device types declared: BlueSensor Wet gel, Ambu King Mask, BlueSensor Solid gel, Neuroline solid gel, Ambu® Disposable Face Mask.
Among these devices, 95 are declared sterile, 32 active, 1 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Ambu A/S (DK) · FDA 9610691 |
| Devices in EUDAMED | 353 |
| Country of registration | Denmark |