Detailed
| 20 | Registration Certificate Number | Xiangqi Zhuzhun 20222141159 |
| 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 type III humanized collagen liquid dressing | |
| Management Category | the second category | |
| Model | 0.5mL/bottle, 1mL/bottle, 1.5mL/bottle, 2mL/bottle, 3mL/bottle, 5mL/bottle, 10mL/bottle, 15mL/bottle, 20mL/bottle, 25mL/bottle, 30mL/bottle, 40mL/bottle, 50mL/bottle, 60mL/bottle, 80mL/bottle, 100mL/bottle, 120mL/bottle, 150mL/bottle, 200mL/bottle. | |
| Structure and Composition/Main Components | The product is composed of recombinant type III humanized collagen, methylcellulose, glycerol, p-hydroxyphenylethanone, 1,2-hexanediol, poloxamer, and purified water, packaged in PET plastic or glass bottles. The product is provided sterile after irradiation sterilization. | |
| Scope of application/intended use | Suitable for the care of non chronic wounds (such as superficial wounds, postoperative suture wounds, mechanical wounds, small wounds, abrasions, cutting wounds, puncture sites of puncture instruments, I degree or shallow II degree burn wounds, and wounds after laser/photon/fruit acid skin exchange/micro plastic surgery), providing a microenvironment for wound healing. Adjuvant treatment for skin inflammation caused by factors such as sores and laser therapy can promote skin repair, shorten the course of the disease, reduce the risk of pigmentation and scar formation after inflammation, improve the skin, and delay skin aging. | |
| Product storage conditions and expiration date | ||
| Attachment | Product Technical Requirements | |
| Other content | Other content | |
| Remark | ||
| Approval department | Hunan Provincial Drug Administration | |
| Approval Date | 2022/6/24 | |
| Effective Date | 2022/6/24 | |
| Valid until | 2027/6/23 | |
| Change situation | On August 14, 2025 at 08:23:55, the structure and composition stated in the registration certificate are composed of "recombinant type III humanized collagen protein, methylcellulose, glycerol, p-hydroxyphenylethanone, 1,2-hexanediol, poloxamer, and purified water, packaged in PET plastic or glass bottles. The product is provided sterile after irradiation sterilization. ”Change to "The product is composed of recombinant type III humanized collagen, methylcellulose, glycerol, p-hydroxyphenylethanone, 1,2-hexanediol, poloxamer, and purified water, packaged in PET plastic bottles, glass bottles, or aluminum bottles. The product is provided sterile after irradiation sterilization. ”2. Please refer to the instruction manual change comparison table for details on the instruction manual changes. |
