ergoline GmbH
GermanyFDA applicant, unverified FDA FEI 3005438755
ergoline GmbH is a medical device manufacturer, with 89 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.
- Devices
- 89
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 86
- FDA 510(k) 3
- Device classes
- FDA Class II 87
- FDA Class I 2
- Identifiers
- FDA FEI 3005438755
- DUNS 314403192
At a glance
Market reach
- United States
- FDA FEI
What ergoline GmbH makes
ergoline GmbH manufactures a range of exercise equipment, including bicycle ergometers for seated, recumbent, and couch-based use, such as the ergoselect 1200 EL and viasprint 150. They also produce professional multichannel electrocardiographs and electromechanical transport trolleys for medical devices. Additionally, the company provides software for spot-check measurement of cardiopulmonary parameters and blood pressure cuffs designed for adult use.
The company’s products are regulated under FDA classifications, with devices falling into Class I and Class II categories. These products are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with US medical device regulations.
Catalogue
Search and filter all 89 devicesShowing 1-50 of 89
Company details
- FDA FEI number
- 3005438755
- DUNS number
- 314403192
- Address
- LINDENSTR. 5, BITZ Baden-Wurttemberg
Frequently asked questions
How many devices does ergoline GmbH have in the registry?
The registry currently lists 89 devices for ergoline GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list ergoline GmbH's devices?
Among its 50 most recently registered devices, ergoline GmbH has devices listed in FDA GUDID (50 devices).
What risk classes do ergoline GmbH's devices fall under?
Among its 50 most recently registered devices, the classes recorded for ergoline GmbH's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from ergoline GmbH in the registry?
The most recently registered devices listed for ergoline GmbH include SYSTEM EBIKE L & BP 120V US 2017911-114, Couch Ergometer ergoselect 1200 EL 230V P BP 1616020, SPLY EBIKE CUFF ADULT LARGE 2017911-012 and ERGOMETER EBIKE L & BP 120V US 2017911-214.