Elcat, GmbH
Country not established
- Devices
- 1
What Elcat, GmbH makes
Elcat GmbH manufactures the HANDYDOP, a portable Doppler ultrasound device designed for non-invasive fetal heart monitoring during pregnancy. This handheld unit provides real-time audio and visual feedback to assess fetal heart rate and detect potential abnormalities.
The HANDYDOP is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
Handydop Ref K030466
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Elcat, GmbH have in the registry?
The registry currently lists 1 device for Elcat, GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elcat, GmbH's devices?
Among its 1 most recently registered device, Elcat, GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Elcat, GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Elcat, GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elcat, GmbH in the registry?
The most recently registered devices listed for Elcat, GmbH include HANDYDOP.