Detailed
| 18 | Registration Certificate Number | Xiangxie Zhuzhun 20232141300 |
| 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 | Medical recombinant collagen repair dressing | |
| Management Category | the second category | |
| Model | 1. (A bottle: 80mg, B bottle: 2mL) 2. (A bottle: 120mg, B bottle: 3mL) 3. (A bottle: 160mg, B bottle: 4mL) 4. (A bottle: 200mg, B bottle: 5mL) 5. (A bottle: 800mg, B bottle: 20mL). | |
| Structure and Composition/Main Components | The A bottle of medical recombinant collagen repair dressing is made of medical polyethylene glycol 400 freeze-dried powder (made of mannitol, water, trehalose, and polyethylene glycol 400 through freeze-drying), and the B bottle is composed of injection water and recombinant collagen, which are packaged separately in penicillin bottles. The product is a disposable product that has undergone radiation sterilization and is supplied sterile. | |
| Scope of application/intended use | The product is suitable for the care of non chronic wounds and surrounding skin such as small wounds, abrasions, and cutting injuries, providing a microenvironment for wound healing. | |
| Product storage conditions and expiration date | ||
| Attachment | Product Technical Requirements | |
| Other content | Other content | |
| Remark | ||
| Approval department | Hunan Provincial Drug Administration | |
| Approval Date | 2023/12/28 | |
| Effective Date | 2023/12/28 | |
| Valid until | 2028/12/27 | |
| Change situation |
