Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006419626

FEI Number

3006419626

Entity Name

GANSHORN MEDIZIN ELECTRONIC GMBH

City/State/Country

Bad Neustadt Bavaria, DE

Establishment Address

Theodor-Jopp-Str. 2, Bad Neustadt Bavaria 97616, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GANSHORN Medizin Electronic GmbH (Owner Number: 10054030)

Owner / Operator Contact Address

Theodor-Jopp-Str. 2, Bad Neustadt, DE-BY 97616, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PowerCube Body+ SpiroDef PowerCube+ Series PowerCube Body+ / Diffusion+ PowerCube Diffusion+ ScoutTube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-12-20
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-12-20
JEH	Plethysmograph, Volume	Anesthesiology	Class 2	868.1760	2024-12-20
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2017-06-19

Official Correspondent

Stefan Ponto

US Agent Details

Ramon Martorell Business: Schiller Americas Email: ramon.martorell@schilleramericas.com Phone: (786) 8450620

Related Public Records

Same Entity

GANSHORN Medizin Electronic GmbH

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
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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3006895489	MEDIKRO OY	Kuopio Pohjois-Savo, FI
3014128536	MEDCHIP SOLUTIONS LIMITED	Chatham Kent, GB
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006419626. Last updated year: 2026. Please use registration number 3006419626 when referencing this establishment in official correspondence.