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:2026-03-16

Starting Validity Date:2026-03-16

Expiry Date:2030-03-06