United Imaging Healthcare Co., Ltd.
Full-spectrum medical-imaging OEM offering CT, MRI, PET/CT, and digital X-ray systems.
United Imaging Healthcare develops and manufactures a complete portfolio of medical-imaging equipment including CT scanners, 3T/5T MRI systems, PET/CT scanners, digital X-ray, mammography, and radiotherapy equipment. The company is listed on the Shanghai STAR Market and has FDA 510(k) clearances for multiple product lines, enabling significant penetration into North American and European hospital markets.
- Type
- Manufacturer
- Location
- Shanghai, China
- Founded
- 2011
- Website
- united-imaging.com
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- China, United States, Germany, Japan, India
Verified facts
- domain-registered (green), checked 2026-08-07 Domain registry record
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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission