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: Ambu King Mask, Ambu Neuroline Monopolar, Ambu Neuroline Subdermal, Ambu® AuraFlex, Ambu® Disposable Face Mask.
Among these devices, 95 are declared sterile, 32 active, 1 with a measuring function.
Devices declared under this manufacturer
- Ambu® AuraFlex
- Ambu® BlueSensor N
- Ambu® BlueSensor NF
- Ambu® BlueSensor R
- Ambu® Disposable Pressure Manometer
- Ambu® King Mask
- Ambu® Mark IV
- Ambu® Neuroline 710
- Ambu® Neuroline Monopolar
- Ambu® Neuroline Twisted Pair Subdermal
- Ambu® Neuroline™ Cup MRI/CT
- Ambu® Redi-ACE
Showing 12 of 353 declared devices.
Catalogue references include 000252051, 299009000, 405011000EUA1, 472001000, 74325-36/40, 74375-50/40.
European nomenclature codes declared: C020501, N010101, R03010101, R01020101, R03010199, N01010202.
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 |
Device-level evidence
| Devices with a numeric GTIN | 353 |
|---|---|
| Found in the U.S. device database | 207 |
| Share | 58.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AMBU A/S |
What it holds in Canada
| Licences on record | 27 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 27 |
| First licensed | 1999-06-28 |
Licence types: Device Family (12), System (10), Device Group Family (3), Device Group (1).
Licensed under: FACEMASK, RESCUE MASK, RESUSCITATOR KITS, PEEP VALVE, BLUESENSOR ECG ELECTRODES, NEUROLINE, DISPOSABLE NEEDLE ELECTRODES, NEUROLINE, DISPOSABLE ELECTRODES.
North American profile: Both markets. Ambu A/S is registered in both the United States and Canada.