Holds certificate No: MD 804964

and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for the following scope:

Registered Scope:

The Design and Development, Manufacture and Distribution of implantable Disposable Sterile Absorbable Hemostatic Ligation Clips, Clip Appliers, implantable Disposable Sterile Multiple Polymer Ligating Clips, Multiple Clip Reusable Appliers, implantable Disposable Sterile Single Polymer Ligating Clips and Single Clip Reusable Appliers for general surgery.

The Design and Development, Manufacture and Distribution of Disposable Sterile Biofragmentable Intestinal Staplers and Intestine Gauges for intestinal surgery. 

Original Registration Date:  30-08-2024

Effective Date: 30-08-2024

Latest Revision Date: 30-08-2024

Expiry Date: 29-08-2027

Company name of Applicant/License No.

Stanley Co., Ltd

Company address of Applicant

T-6043,66,Chungmin-ro, Songpa-gu,Seoul,Republic of Korea

Name of Manufacturer

Hangzhou Sunstone Technology Co., Ltd.

Address of Manufacturer

1st and 2nd floors,building 2,460 Fucheng Road,Qiantang New district,Hangzhou City,Zhejiang Province,China

Category

Instrument for medical Procedure

(We hereby certify that the above manufacturer complies with Korea Good Manufacturing Practices of Medical Devices for the product group listed above)

Date of Issue: 2023.09.27

Date of Expiration: 2026.09.26