EU Quality Management System Certificate
Regulation (EU)2017/745, Annex Ix Chapter I and III
MDR 804963 R000
Manufacturer: Hangzhou Sunstone Technology Co., Ltd
Address:
2nd Floor of Building 1,
#460 Fucheng Rd, Qiantang Area
Hangzhou
Zhejiang
310018
China
Single Registration Number: CN-MF-000040501
EU Authorised Representative: MedPath GmbH
Address:
Mies-van-der-Rohe-Strasse 8
80807
Munich
Germany
Scope: See attached Device Schedule
On the basis of our examination of the quality system in accordance with Regulation (EU) 2017/745, Annex IX
Chapter I and lll, the quality system meets the requirements of the Regulation. For the placing on the market of
Class Ill devices, and Class llb implantable devices that are not considered well-established technologies as specifed
in Article 52(4) an additional Annex IX Chapter II certificate is required.
First Issue Date:2025-03-07
Curent Issue Date:2025-03-07
Starting Validity Date:2025-03-07
Expiry Date:2030-03-06
Media Contact
Company Name: Hangzhou Sunstone Technology Co., Ltd.
Email: Send Email
Phone: 86-571-88868125
Country: China
Website: https://www.sunstonemd.com/