Edan Instruments, Inc.
12-lead ECG systems, patient monitors and ultrasound for clinical wholesale.
Edan Instruments develops and manufactures 12-lead ECG systems, bedside patient monitors and handheld ultrasound devices. Founded in Shenzhen, it operates R&D centres in China and Germany and holds CE, FDA and Health Canada registrations. Products are distributed through hospital equipment dealers in Europe, North America and Southeast Asia.
- Type
- Manufacturer
- Location
- Shenzhen, China
- Founded
- 2000
- Website
- edan.com
- Categories
- Medical & Healthcare Supplies
- Markets
- China, Germany, United States, France, United Kingdom
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-05 Mail server of the company domain
- domain-registered (green), checked 2026-08-05 Domain registry record
- debarment-clear (green), checked 2026-08-05 OpenSanctions
- fda-registered (green), checked 2026-08-05 FDA
- lei-lapsed (amber), checked 2026-08-05 GLEIF
- sanctions-clear (green), checked 2026-08-05 OpenSanctions
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)