| 2 | Registration Certificate Number | Xiangxie Zhuzhun 20252200242 |
| Registrant Name | Hunan Xinxie Kang Medical Equipment Co., Ltd |
| Registrant's domicile | 3rd Floor, Building 10, Innovation and Entrepreneurship Center, No. 31 Dongfeng Road, Xiangtan Economic Development Zone |
| Production Address | 3rd Floor, Building 10, Innovation and Entrepreneurship Center, No. 31 Dongfeng Road, Xiangtan Economic Development Zone |
| Product name | Disposable sterile skin roller needle |
| Management Category | the second category |
| Model | 0.20×0.5mm、0.20×1.0mm、0.20×1.5mm、0.20×2.0mm |
| Structure and Composition/Main Components | Composed of handle (including bracket), roller, roller plate, stainless steel needle plate, and protective cover. The stainless steel needle plate is made of 06Cr19Ni10N austenitic stainless steel plate, and the handle (including bracket), roller, roller plate, and protective cover are made of medical grade polycarbonate. There are 8 needle plates with a needle body diameter of 0.2mm, 7 roller plates with a roller diameter of 20mm, and they are divided into 4 types according to different sizes. The product is sterilized with ethylene oxide and should be sterile and disposable. |
| Scope of application/intended use | Used for local stimulation of specific parts of the body surface, implementing rolling needle therapy. |
| Product storage conditions and expiration date |
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| Attachment | Product Technical Requirements |
| Other content | Other content |
| Remark |
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| Approval department | Hunan Provincial Drug Administration |
| Approval Date | 2025/3/10 |
| Effective Date | 2025/3/10 |
| Valid until | 2030/3/9 |
| Change situation |
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