Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011846517

FEI Number

3011846517

Entity Name

ORTHOSCOOT GMBH

City/State/Country

Neusas Bavaria, DE

Establishment Address

Gessertshausener Strasse 2, Neusas Bavaria 86356, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Orthoscoot GmbH (Owner Number: 10056989)

Owner / Operator Contact Address

Gessertshausener Strasse 2, Neusaess/Vogelsang, DE-BY 86356, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthoscoot NH1 Orthoscoot DH1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2018-02-07

Official Correspondent

Dennis Soeter

US Agent Details

Darrell Londene Email: d.londene@orthoscoot.com Phone: (505) 8771491

Related Public Records

Same Entity

Orthoscoot 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 3011846517. Last updated year: 2026. Please use registration number 3011846517 when referencing this establishment in official correspondence.