| 11 | Registration Certificate Number | Xiangqi Zhuzhun 20222141959 |
| 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 | Scar ointment |
| Management Category | the second category |
| Model | 1. Model: BH (G) -01, specification: 2.5g; Model: BH (G) -02, specification: 3g; Model: BH (G) -03, specification: 3.5g; Model: BH (G) -04, specification: 5g; Model: BH (G) -05, specification: 10g; Model: BH (G) -06, specification: 15g; Error: not less than 93% of the indicated quantity. 2. Model: BH (G) -07, specification: 20g; Model: BH (G) -08, specification: 30g; Model: BH (G) -09, specification: 50g; Error: not less than 95% of the indicated loading capacity. 3. Model: BH (G) -10, specification: 80g; Model: BH (G) -11, specification: 100g; Error: not less than 97% of the indicated loading quantity. |
| Structure and Composition/Main Components | The product is composed of medical silicone oil (dimethyl silicone oil), glycerin, carboxymethyl cellulose, and purified water, and is encapsulated in polyethylene plastic tubing. |
| Scope of application/intended use | Suitable for the prevention and treatment of burns, scalds, wounds, and postoperative scars, not for unhealed wounds. |
| Product storage conditions and expiration date |
|
| Attachment | Product Technical Requirements |
| Other content | Other content |
| Remark |
|
| Approval department | Hunan Provincial Drug Administration |
| Approval Date | 2022/10/26 |
| Effective Date | 2022/10/26 |
| Valid until | 2027/10/25 |
| Change situation |
|