Ambu Innovation GmbH
GermanyFDA applicant, unverified FDA FEI 3016497307
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Ambu Innovation GmbH makes
Ambu Innovation GmbH manufactures the Ambu Duodeno System, a medical device designed for duodenal access and feeding, enabling nutritional support and diagnostic procedures in clinical settings.
The device is classified as Class II under regulatory frameworks and has been authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Ambu Duodeno System Ref K201098
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3016497307
- Address
- Karl-Drais-Str. 4B, Augsburg Bavaria
Frequently asked questions
How many devices does Ambu Innovation GmbH have in the registry?
The registry currently lists 1 device for Ambu Innovation GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ambu Innovation GmbH's devices?
Among its 1 most recently registered device, Ambu Innovation GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Ambu Innovation GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ambu Innovation GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ambu Innovation GmbH in the registry?
The most recently registered devices listed for Ambu Innovation GmbH include Ambu Duodeno System.