| 21 | Registration Certificate Number | Xiangqi Zhuzhun 20212140051 |
| 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 hyaluronic acid dressing | |
| Management Category | the second category | |
| Model | See the attachment | |
| Structure and Composition/Main Components | Medical hyaluronic acid dressings (hereinafter referred to as "products") are made by encapsulating hyaluronic acid solution and PET bottles or glass bottles, or by encapsulating hyaluronic acid solution, non-woven fabric, isolation paper, and aluminum foil bags. Hyaluronic acid stock solution is composed of sodium hyaluronate, triethanolamine, carbomer, and purified water. The product is a disposable product. After radiation sterilization, it should be sterile. | |
| Scope of application/intended use | The product is suitable for the care of non chronic wounds in the human body, providing a microenvironment for superficial wounds, first degree or shallow second degree burn wounds, and wound healing after laser surgery. | |
| Product storage conditions and expiration date | ||
| Attachment | Product Technical Requirements | |
| Other content | Other content | |
| Remark | ||
| Approval department | Hunan Provincial Drug Administration | |
| Approval Date | 2025/7/14 | |
| Effective Date | 2026/1/5 | |
| Valid until | 2031/1/4 | |
| Change in Situation |
2021-07-01 00:00:00 1. Change of residence from "2nd Floor, Building 2, Supporting Room for Box Steel Structure Standard Factory Building, No. 5 Yaai Road, Xiangtan Economic Development Zone Innovation and Entrepreneurship Center" to "Room 118, A4-203 Factory Building, Phase I, Tianyuan District, Zhuzhou City, Hunan Province". 2. Change the production address from "2nd Floor, Building 2, Supporting Building for Box Steel Structure Standard Factory Building, No. 5 Yaai Road, Xiangtan Economic Development Zone" to "Room 104, 204, 304, Building 4, Phase A, Tianyi Science and Technology City, Tianyi Science and Technology City, Tianyi Science and Technology City, Phase I, New Generation Information Industry Park, Zhuzhou City, Hunan Province". 3. Add other content to the original registration certificate: Medical device registrant system. 4. Add the following remarks to the original registration certificate: (1) Entrusted enterprise: Hunan Muta Biotechnology Development Co., Ltd; (2) Deadline for commissioned production: January 24, 2025. 2022-06-29 00:00:00 1. Change the applicant's residence from "Room 118, Factory A4-203, Phase I, Tianyuan District, Zhuzhou City, Hunan Province" to "3rd Floor, Building 10, Innovation and Entrepreneurship Center, No. 31 Dongfeng Road, Xiangtan Economic Development Zone". 2022-09-27 00:00:00 1. No longer entrust Hunan Muta Biotechnology Development Co., Ltd. to produce, the production address has been changed from "Room 104, 204, 304, Building 4, Phase A, Tianyi Science and Technology City New Generation Information Industry Park, Tianyuan District, Zhuzhou City, Hunan Province" to "3rd Floor, Building 10, Innovation and Entrepreneurship Center, No. 31 Dongfeng Road, Xiangtan Economic Development Zone". 2023-01-16 00:00:00 1. Change of model specifications: The product model specifications have been changed from YF (T) - A (circular, diameter: 8cm, 15cm, 20cm, 22cm, 24cm, 25cm, 26cm, 30cm); YF (T) - B (square, length x width: 6cm x 10cm, 15cm x 10cm, 10cm x 20cm, 10cm x 40cm, 20cm x 10cm, 22cm x 10cm, 22cm x 25cm, 24cm x 10cm, 25cm x 30cm, 30cm x 10cm, 30cm x 40cm, 35cm x 40cm, 40cm x 60cm); YF (T) - C (elliptical, transverse diameter x longitudinal diameter: 18cm x 20cm, 22cm x 21cm, 22cm x 23cm, 24cm x 21cm, 25cm x 22cm, 26cm x 21cm, 26cm x 23cm). ”Change to YF (T) - A (circular, diameter: 8cm, 15cm, 20cm, 22cm, 24cm, 25cm, 26cm, 30cm); YF (T) - B (square, length x width: 6cm x 10cm, 15cm x 10cm, 10cm x 20cm, 10cm x 40cm, 20cm x 10cm, 22cm x 10cm, 22cm x 25cm, 24cm x 10cm, 25cm x 30cm, 30cm x 10cm, 30cm x 40cm, 35cm x 40cm, 40cm x 60cm); YF (T) - C (elliptical, transverse diameter x longitudinal diameter: 18cm x 20cm, 22cm x 21cm, 22cm x 23cm, 24cm x 21cm, 25cm x 22cm, 26cm x 21cm, 26cm x 23cm); YF (T) - D (1.0ml/bottle, 1.5ml/bottle, 2ml/bottle, 5ml/bottle, 25ml/bottle, 30ml/bottle, 60ml/bottle, 100ml/bottle); 2. Change of structural composition: The product structure composition consists of "medical hyaluronic acid dressing" which is composed of hyaluronic acid raw material, non-woven fabric, and isolation paper, packaged in aluminum foil bags. The product is a disposable product and should be sterile after Co60 sterilization. ”Change to "Medical hyaluronic acid dressing (hereinafter referred to as the product) is made by encapsulating hyaluronic acid solution and PET bottles or glass bottles, or by encapsulating hyaluronic acid solution, non-woven fabric, isolation paper, and aluminum foil bags. Hyaluronic acid stock solution is composed of sodium hyaluronate, triethanolamine, carbomer, and purified water. The product is a disposable product. After radiation sterilization, it should be sterile. ”; 3. Change product technical requirements: see the comparison table of product technical requirement changes for details; 2024-04-26 00:00:00 1. Change the product technical requirements, please refer to the attached product technical requirement change comparison table for details. |