| 22 | Registration Certificate Number | Xiangqi Zhuzhun 20222142212 |
| 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 | Mytilus mucin hydrogel dressing |
| Management Category | the second category |
| Model | 500 μ g/g type: (1g/vial, 2g/vial, 3g/vial, 5g/vial, 8g/vial, 10g/vial, 15g/vial, 20g/vial) 1000 μ g/g type: (1g/vial, 2g/vial, 3g/vial, 5g/vial, 8g/vial, 10g/vial, 15g/vial, 20g/vial) 1500 μ g/g type: (1g/vial, 2g/vial, 3g/vial, 5g/vial, 8g/vial, 10g/vial, 15g/vial, 20g/vial) |
| Structure and Composition/Main Components | The product is composed of mussel mucin, methylcellulose, propylene glycol, glycerol, citric acid, and injection water, packaged in PET plastic or glass bottles, sterilized by irradiation, and supplied aseptically for one-time use. |
| Scope of application/intended use | Suitable for the protection of superficial non chronic wounds. |
| 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 | 2022/12/26 |
| Effective Date | 2022/12/26 |
| Valid until | 2027/12/25 |
| Change situation | 2023 September 6th 00:00:00 1. Change of model and specifications: Please refer to the registration certificate information change comparison table for details. 2. Change structure and composition: Please refer to the registration certificate information change comparison table for details. 3. Change product technical requirements: Please refer to the Product Technical Requirements Change Comparison Table for details. |
