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Sign in to claim this brandGanshorn Medizin Electronic GmbH
US
Last updated May 30, 2026
Part of Ganshorn Medizin Electronic Gmbh
What Ganshorn Medizin Electronic GmbH makes
Ganshorn Medizin Electronic GmbH manufactures pulmonary function analysis systems for adults, including professional diagnostic spirometers designed for clinical use. Their portfolio also includes disposable breathing mouthpieces and specialized filters/mouthpieces for pulmonary function testing. The company produces a range of spirometry devices, such as the SpiroScout SP series and SpiroDef, as well as portable testing units like the PowerCube+ Series.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, where regulatory compliance follows FDA guidelines for medical devices. The manufacturer is based in Germany, though its devices are authorized for distribution in the US market.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Ganshorn Medizin Electronic GmbH manufacture?
Ganshorn Medizin Electronic GmbH specializes in pulmonary function analysis systems for adults. Their product range includes professional diagnostic spirometers, which are used in clinical settings to measure lung function, as well as disposable breathing mouthpieces and specialized filters/mouthpieces for pulmonary function testing. Examples include the SpiroScout SP series, SpiroDef, and the portable PowerCube+ Series.
Where is Ganshorn Medizin Electronic GmbH based, and where are their devices authorized for use?
Ganshorn Medizin Electronic GmbH is based in Germany, though its devices are authorized for distribution and use in the United States. The company’s products comply with FDA guidelines for medical devices, ensuring they meet regulatory requirements for the US market.
Which regulatory registries or databases list Ganshorn Medizin Electronic GmbH’s devices?
Ganshorn Medizin Electronic GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Ganshorn Medizin Electronic GmbH’s devices classified under FDA regulations?
Ganshorn Medizin Electronic GmbH’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
What is the purpose of the devices manufactured by Ganshorn Medizin Electronic GmbH?
The devices manufactured by Ganshorn Medizin Electronic GmbH are designed for pulmonary function testing, which includes assessing lung capacity, airflow, and overall respiratory health in adult patients. These systems are critical for diagnosing and monitoring conditions like asthma, COPD, and other respiratory disorders in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ganshorn.de
- —
- —
- [email protected]
- Phone
- +49977162220
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 318498177
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SpiroScout SP plus | Rev.D | FDA UDI | Class II | Active |
| SpiroDef | A | FDA UDI | Class I | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Unknown |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| SpiroScout SP | A | FDA UDI | Class II | Active |
| SpiroDef | A | FDA UDI | Class I | Active |
| SpiroScout SP | A | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Unknown |
| PowerCube+ Series | A | FDA UDI | Class II | Unknown |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Unknown |
| ScoutTube | 019420620 | FDA UDI | Class I | Active |
| SpiroScout | 04421 | FDA UDI | Class II | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Active |
| SpiroDef | A | FDA UDI | Class I | Active |
| PowerCube+ Series | A | FDA UDI | Class II | Unknown |
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