| 6 | Registration Certificate Number | Xiangxie Zhuzhun 20252140341 |
| 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 | Silk fibroin liquid dressing |
| Management Category | the second category |
| Model | 1.0mL/bottle, 1.5mL/bottle, 2mL/bottle, 3mL/bottle, 5mL/bottle, 10mL/bottle, 15mL/bottle, 20mL/bottle, 25mL/bottle, 30mL/bottle, 60mL/bottle, 100mL/bottle. |
| Structure and Composition/Main Components | Silk fibroin liquid dressing is composed of silk fibroin and purified water, packaged in glass bottles. The product is a disposable product that has undergone wet heat sterilization and sterile supply. |
| Scope of application/intended use | Used for the care of non chronic wounds such as small incisions, abrasions, cuts, and surrounding skin。 |
| 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 | 2025/4/7 |
| Effective Date | 2025/4/7 |
| Valid until | 2030/4/6 |
| Change situation | On August 20, 2025 at 16:32:08, the structure and composition of the silk fibroin liquid dressing were changed from "silk fibroin liquid dressing is composed of silk fibroin and purified water, packaged in glass bottles, and the product is a disposable product that has been sterilized by wet heat and supplied aseptically." to "silk fibroin liquid dressing is composed of silk fibroin and purified water, packaged in glass bottles or medicinal borosilicate glass tubes (equipped with brominated butyl rubber pistons and polypropylene caps), and the product is a disposable product that has been sterilized by wet heat and supplied aseptically; 2. Change the specifications and models from 1.0mL/bottle, 1.5mL/bottle, 2mL/bottle, 3mL/bottle, 5mL/bottle, 10mL/bottle, 15mL/bottle, 20mL/bottle, 25mL/bottle, 30mL/bottle, 60mL/bottle, and 100mL/bottle. ”Change to "Glass Bottle: 1.0 mL、1.5mL、2mL、3mL、5mL、10mL、15mL、20mL、25mL、30mL、60mL、100mL； Medicinal borosilicate glass tubes: 1.0mL, 1.5mL, 2mL, 3mL, 5mL; 3. Change product technical requirements, please refer to the Product Technical Requirements Change Comparison Table for details. |
