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Medical AI Co., Ltd.

South Korea·KR-MF-000045682

Last updated September 18, 2026

About

Medical AI's mission and vision are to connect people with innovative medical technology everywhere and at all times to overcome treatable and preventable diseases so humanity can lead a sustainable and healthy life.

From the manufacturer's own website. Source

What Medical AI Co., Ltd. makes

Medical AI Co., Ltd. develops AI-driven diagnostic devices, including the AiTiALVDD for left ventricular diastolic dysfunction assessment, the AiTiAMI for atrial myocardial infarction detection, and the AiTiALVSD for left ventricular systolic dysfunction evaluation. These tools utilize AI algorithms to analyze medical imaging data for automated diagnostic support in cardiology.

The company’s devices are classified as Class IIa under EU regulations and are registered in the eudamed database. Medical AI Co., Ltd. is based in South Korea.

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 Medical AI Co., Ltd. manufacture?

Medical AI Co., Ltd. specializes in AI-driven diagnostic devices for cardiology. Their portfolio includes tools like the AiTiALVDD, which assesses left ventricular diastolic dysfunction, the AiTiAMI for detecting atrial myocardial infarction, and the AiTiALVSD for evaluating left ventricular systolic dysfunction. These devices use AI algorithms to analyze medical imaging data to assist in automated diagnostic support.

Where is Medical AI Co., Ltd. based?

Medical AI Co., Ltd. is headquartered in South Korea. The company’s location in South Korea positions it to serve global markets while leveraging regional expertise in medical technology development.

Which regulatory registries list Medical AI Co., Ltd.’s devices?

Medical AI Co., Ltd.’s devices are registered in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion ensures transparency and compliance with EU regulatory requirements for Class IIa devices.

How are Medical AI Co., Ltd.’s devices classified under EU regulations?

Medical AI Co., Ltd.’s devices fall under Class IIa classification in the EU. This classification is determined based on the risk associated with the device’s intended purpose and design, with Class IIa representing moderate-risk devices requiring additional scrutiny to ensure safety and performance.

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

Information

Country
South Korea
Address
38, Yeongdong-daero 85-gil, Seoul, South Korea
LinkedIn
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Facebook
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Phone
+82-2-2058-0521
PRRC Contact
Yejin Lee
EUDAMED SRN
KR-MF-000045682
FDA FEI Number
—
DUNS Number
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Catalogue (3)

DeviceModel / ReferenceRegistriesClassStatus
AiTiALVDD AiTiALVDD
EUDAMED
Class IIaActive
AiTiAMI AiTiAMI
EUDAMED
Class IIaActive
AiTiALVSD AiTiALVSD
EUDAMED
Class IIaActive

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