Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016497307

FEI Number

3016497307

Entity Name

AMBU INNOVATION GMBH

City/State/Country

Augsburg Bavaria, DE

Establishment Address

Karl-Drais-Str. 4B, Augsburg Bavaria 86159, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ambu A/S (Owner Number: 10076603)

Owner / Operator Contact Address

Baltorpbakken 13, Ballerup, DK-84 2750, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201098

PMA Number

N/A

All Registered Proprietary Names

Ambu aBox Duodeno Ambu aScope Duodeno

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-07-27
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-07-27

Official Correspondent

Kristine Rasmussen

US Agent Details

Sanjay Parikh Business: Ambu Inc Email: SAP@ambu.com Phone: (410) 7686464

Related Public Records

Same Entity

Ambu A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016497307. Last updated year: 2026. Please use registration number 3016497307 when referencing this establishment in official correspondence.