Edan Instruments, Inc.

深圳市理邦精密仪器股份有限公司

Edan Instruments, Inc. is a Shenzhen-based medical device manufacturer founded in 1995 and listed on the Shenzhen Stock Exchange ChiNext (300206). It develops patient monitoring and life support, diagnostic ECG, obstetrics/gynecology, ultrasound imaging, point-of-care testing and in-vitro diagnostics, with over 100 products sold in more than 170 countries. The company operates four global R&D centres and reported revenue of roughly RMB 1.83-2.00 billion for 2024-2025.

EU MDR Quality Management System certificate (TUV SUD Product Service GmbH, Notified Body 0123, cert. no. G10 091264 0025 Rev. 01) covering Class IIa/IIb devices including Vital Signs Monitoring InstrumentsFDA 510(k) K131971 (IM60/IM70 Patient Monitor, 2014-03-20) and K202336 (Patient Monitor, 2021-01-23)ISO 14001 environmental management system and China CMD quality management system (per official company timeline)

1 listed product

Video Medical Devices & Health Equipment

Edan Instruments, Inc.

Edan iM80 Patient Monitor

15-inch high-acuity modular patient monitor with up to 13 waveforms

Patient Monitor
EU MDR Quality Management System certificate (TUV SUD, cert. no. G10 091264 0025 Rev. 01) covering Class IIb Vital Signs Monitoring Instruments - not a model-specific iM80 product certificate · Documented as compliant with IEC/EN 60601-1, 60601-2-27, -2-30, -2-34, -2-49, -2-25 and -2-51, ANSI/AAMI EC13 and ANSI/AAMI SP10 in Edan's published specification

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