Data / Medical devices / Germany / Ambu Innovation GMBH
Ambu Innovation GMBH: FDA-registered device maker in Augsburg Bavaria, Germany, 1 510(k) clearance
Ambu Innovation GMBH is registered with the FDA (registration 3016497307) in Augsburg Bavaria, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016497307
- Address
- Karl-Drais-Str. 4B, Augsburg Bavaria, Germany, 86159
- Owner or operator
- Ambu A/S (10076603)
- Roles
- Specification developer
- First device listed
- July 27, 2020
- Registered through
- 2026
- Brand names listed
- Ambu aBox Duodeno, Ambu aScope Duodeno
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Duodenoscope And Accessories, Flexible/Rigid | FDT | 2 | Specification developer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2020 | K201098 | Ambu Duodeno System | FDT | Substantially Equivalent | Ambu Innovation GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Duodenoscope And Accessories, Flexible/Rigid
Updated July 17, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.