Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (Yuwell)
China's best-selling home-healthcare brand: oximeters, CPAP, blood-glucose meters, and wheelchairs.
Yuwell Medical manufactures a full range of home-care medical devices including pulse oximeters, blood-pressure monitors, blood-glucose meters, CPAP/BiPAP respiratory devices, nebulisers, and mobility aids. One of China's top-three consumer-medical brands by retail volume, Yuwell exports to over 160 countries and was a major global supplier of oximeters during the COVID-19 pandemic.
- Type
- Manufacturer
- Location
- Danyang, China
- Founded
- 1998
- Website
- yuwell.com
- Categories
- Medical & Healthcare Supplies
- Markets
- China, United States, Germany, Australia, India
Verified facts
- domain-registered (green), checked 2026-08-13 Domain registry record
- debarment-clear (green), checked 2026-08-13 OpenSanctions
- sanctions-clear (green), checked 2026-08-13 OpenSanctions
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)