United Imaging Healthcare Co., Ltd.
OEM pencitraan medis spektrum penuh yang menawarkan sistem CT, MRI, PET/CT, dan sinar-X digital.
United Imaging Healthcare mengembangkan dan memproduksi portofolio lengkap peralatan pencitraan medis termasuk pemindai CT, sistem MRI 3T/5T, pemindai PET/CT, sinar-X digital, mamografi, dan peralatan radioterapi. Perusahaan ini terdaftar di Shanghai STAR Market dan memiliki izin FDA 510(k) untuk berbagai lini produk, sehingga memungkinkan penetrasi yang signifikan ke pasar rumah sakit Amerika Utara dan Eropa.
- Type
- Manufacturer
- Location
- Shanghai, China
- Founded
- 2011
- Website
- united-imaging.com
- Categories
- Perlengkapan Medis & Kesehatan, Mesin Industri
- Markets
- Tiongkok, Amerika Serikat, Jerman, Jepang, 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