Eu Mdr Eu Md Class 2a On The Market 🇩🇪 Germany

clinalytix

DH Healthcare GmbH · 🇩🇪 Germany
Devices (same UDI-DI)
5
Certificates
0
Countries
2
Notified Bodies
0

Basic Information

Primary DI
04260693990101
Basic UDI-DI Code
426069399CLINALYTIXH4
Reference
clinalytix Medical A
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
DH Healthcare GmbH

Additional Description

clinalytix Medical AI consists of clinical prediction services, each estimating, for a given patient, the risk of one type of clinical event. The predictions may assist the treating physician as an additional source for risk estimation, and are intended to complement, i.e. enhance rather than replace, established detection methods or practices. Currently, the services predict the risk of occurrence of: • an episode of delirium during the hospitalization; • an episode of sepsis during the hospitalization; • an episode of acute kidney injury during the hospitalization. clinalytix Medical AI does not provide stand-alone prediction services: each service is intended to be integrated into (third-party) HIS applications. The inpatient’s treating physician use the result of the prediction services in combination with established risk estimation and detection methods and practices, to estimate the patient’s risk of developing the condition that is specific for each service.

CND Nomenclature Codes

Code Description
Z120499 GENERAL MEDICINE INSTRUMENTS - OTHER

Available In Countries

🇦🇹 Austria 🇩🇪 Germany

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