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KOALYS TECHNOLOGIES LTD

Israel·IL-MF-000051836

Last updated May 30, 2026

What KOALYS TECHNOLOGIES LTD makes

Koalys Technologies Ltd manufactures Koalys Consult, a software-based medical device designed for clinical decision support and patient monitoring in healthcare settings. The product integrates with electronic health records to assist clinicians in diagnostic and treatment planning processes, particularly in cardiology and neurology.

The company’s portfolio is classified under EU Class IIa devices and is registered in the EUDAMED database. Koalys Technologies Ltd is headquartered in Israel.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Koalys Technologies Ltd manufacture?

Koalys Technologies Ltd manufactures software-based medical devices, specifically Koalys Consult. This device is designed for clinical decision support and patient monitoring, helping clinicians in diagnostic and treatment planning—particularly in cardiology and neurology—by integrating with electronic health records.

Where is Koalys Technologies Ltd based?

Koalys Technologies Ltd is headquartered in Israel, as stated in their company information.

Which regulatory registries list Koalys Technologies Ltd’s devices?

Koalys Technologies Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and monitor medical devices authorized within the EU.

How are Koalys Technologies Ltd’s devices classified under EU regulations?

Koalys Technologies Ltd’s devices fall under EU Class IIa classification. This classification is assigned based on the risk associated with the device, with Class IIa representing moderate-risk medical devices that require additional scrutiny and compliance measures to ensure safety and performance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Israel
Address
20, King George Street , Jerusalem, Israel
LinkedIn
—
Facebook
—
Phone
+972186261199
PRRC Contact
Elodie Vincent
EUDAMED SRN
IL-MF-000051836
FDA FEI Number
—
DUNS Number
600023242

Catalogue (1)

DeviceModel / ReferenceRegistriesClassStatus
Koalys Consult (01)0729001782001
EUDAMEDFDA UDI
Class IIaActive

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