Comarch Healthcare SA
PolandFDA 510(k) applicant, unverified
- Devices
- 1
What Comarch Healthcare SA makes
Comarch Healthcare SA develops the Comarch e-Care Platform, a digital health solution designed to support remote patient monitoring, clinical data aggregation, and interoperable healthcare workflows for providers and care teams.
The platform is classified as Class II under FDA regulations and is listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Comarch e-Care Platform Ref K181248
510(k) 510(k)
Frequently asked questions
How many devices does Comarch Healthcare SA have in the registry?
The registry currently lists 1 device for Comarch Healthcare SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Comarch Healthcare SA's devices?
Among its 1 most recently registered device, Comarch Healthcare SA has devices listed in FDA 510(k) (1 device).
What risk classes do Comarch Healthcare SA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Comarch Healthcare SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Comarch Healthcare SA in the registry?
The most recently registered devices listed for Comarch Healthcare SA include Comarch e-Care Platform.