Detailed
| 16 | Registration Certificate Number | Xiangqi Zhuzhun 20242140563 |
| 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 | Third Floor, Building 10, New Entrepreneurship Center, Medical Recombinant Collagen Composite Solution | |
| Management Category | the second category | |
| Model | 2mL/bottle, 5mL/bottle, 7mL/bottle, 10mL/bottle, 15mL/bottle, 20mL/bottle | |
| Structure and Composition/Main Components | The medical recombinant collagen composite solution is composed of recombinant collagen, sodium hyaluronate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, and injection water. The internal packaging of the product is made of medicinal borosilicate glass tubes. The product is processed using aseptic technology and provided in a sterile form for one-time use. | |
| Scope of application/intended use | Used for the care of non chronic wounds such as small incisions, abrasions, and cuts, as well as surrounding skin, serving as a physical barrier. | |
| Product storage conditions and expiration date | ||
| Attachment | Product Technical Requirements | |
| Other content | Other content | |
| Remark | ||
| Approval department | Hunan Provincial Drug Administration | |
| Approval Date | 2024/7/3 | |
| Effective Date | 2024/7/3 | |
| Valid until | 2029/7/2 | |
| Change situation | 2024-12-11 00:00:00 1. For details on changes to the content of the product registration certificate, please refer to the comparison table of changes to the content of the product registration certificate; 2. For detailed changes in product technical requirements, please refer to the Product Technical Requirements Change Comparison Table. |
