Hellige GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Hellige GmbH makes
Hellige GmbH manufactures the Cardio Serv, a medical device designed for cardiac monitoring and stress testing, used to evaluate heart function under controlled physical exertion.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices and is listed in the US regulatory registry. The manufacturer is based in the United States.
Catalogue
Cardio Serv Ref K951110
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hellige GmbH have in the registry?
The registry currently lists 1 device for Hellige GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hellige GmbH's devices?
Among its 1 most recently registered device, Hellige GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Hellige GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Hellige GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hellige GmbH in the registry?
The most recently registered devices listed for Hellige GmbH include CARDIO SERV.