Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004091741

FEI Number

3004091741

Entity Name

AXEL GENTNER GMBH

City/State/Country

Tuttlingen Baden-Wurttemberg, DE

Establishment Address

Gaensaecker 24, Tuttlingen Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Axel Gentner GmbH (Owner Number: 10094601)

Owner / Operator Contact Address

Gaensaecker 24, Tuttlingen, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cleaning Adapter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2025-12-10

Official Correspondent

Peter Gentner

US Agent Details

Anja Fair Email: Anja.Fair@karlstorz.com Phone: (424) 2188738

Related Public Records

Same Entity

Axel Gentner GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004091741. Last updated year: 2026. Please use registration number 3004091741 when referencing this establishment in official correspondence.