Landwind Medical Holdings Limited
Designer and OEM manufacturer of ECG, pulse oximetry and patient monitoring devices.
Landwind Medical develops and manufactures portable ECG monitors, multi-parameter patient monitors, pulse oximeters and digital sphygmomanometers for hospital and home-care markets. The company holds FDA 510(k) clearances and CE marks across its core product lines and acts as OEM partner for European and American medical equipment distributors requiring low-cost, regulatory-compliant hardware.
- Type
- Manufacturer
- Location
- Shenzhen, China
- Founded
- 2004
- Website
- landwindmedical.com
- Categories
- Medical & Healthcare Supplies
- Markets
- China, United States, Germany, Australia, Canada
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- FDA Registered FDA Establishment Registration
- CE Marking EU NANDO (notified bodies)
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)