Detailed
| 23 | Registration Certificate Number | Xiangxie Zhuzhun 20212140487 |
| 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 | Room 104, 204, 304, Building 4, Phase A, Tianyi Science and Technology City New Generation Information Industry Park, Tianyuan District, Zhuzhou City, Hunan Province | |
| Product name | Hyaluronic acid gel dressing | |
| Management Category | the second category | |
| Model | YF（N）-01、YF（N）-02、YF（N）-03、YF（N）-04、YF（N）-05、YF（N）-06、YF（N）-07、YF（N）-08、YF（N）-09、YF（N）-10、YF（N）-11、YF（N）-12、YF（N）-13、YF（N）-14、YF（N）-15、YF（N）-16、YF（N）-17、YF（N）-18、YF（N）-19、YF（N）-20YF（N）-21 | |
| Structure and Composition/Main Components | Hyaluronic acid gel dressing consists of hyaluronic acid stock solution (sodium hyaluronate, carbomer 980, triethanolamine and purified water) and buffer solution (citric acid, sodium citrate). Encapsulated in polyethylene plastic pipes or glass bottles. The product is a disposable product and should be sterile after Co60 sterilization. | |
| Scope of application/intended use | The product is suitable for superficial wound care. | |
| Product storage conditions and expiration date | ||
| Attachment | Product Technical Requirements | |
| Other content | Other content | |
| remark | 1. Entrusted enterprise: Hunan Muta Biotechnology Development Co., Ltd. 2. Commissioned production deadline: April 12, 2026 | |
| Approval department | Hunan Provincial Drug Administration | |
| Approval Date | 2022/5/18 | |
| Effective Date | 2021/4/13 | |
| Valid until | 2026/4/12 | |
| change situation | 2022-01-04 00:00:00 1. Product model specifications changed to "YF (N) -01, YF (N) -02, YF (N) -03, YF (N) -04, YF (N) -05, YF (N) -06, YF (N) -07, YF (N) -08, YF (N) -09, YF (N) -10, YF (N) -11, YF (N) -12, YF (N) -13, YF (N) -14, YF (N) -15, YF (N) -16, YF (N) -17, YF (N) -18, YF (N) -19, YF (N) -20YF (N) -21". 2. Change the product structure and composition to "hyaluronic acid gel dressing is composed of hyaluronic acid stock solution and buffer solution. It is packaged with polyethylene plastic tube or glass bottle. The product is disposable and sterile after Co60 sterilization. ” 2022-05-18 00:00:00 1. Change the applicant's residence from "2nd Floor, Building 2, Supporting Room for Box Steel Structure Standard Factory Building, Innovation and Entrepreneurship Center, No. 5 Yaai Road, Xiangtan Economic Development Zone" to "3rd Floor, Building 10, Innovation and Entrepreneurship Center, No. 31 Dongfeng Road, Xiangtan Economic Development Zone". 2. Change the production address from "2nd Floor, Building 2, Supporting Room for Box Steel Structure Standard Factory Building, No. 5 Ya'ai Road, Xiangtan Economic Development Zone" to "Room 104, 204, 304, Building 4, Phase A, Tianyi Science and Technology City, Tianyi Science and Technology City, Tianyuan District, Zhuzhou City, Hunan Province". 3. Other contents of the original registration certificate have been added: 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: April 12, 2026. 2022-09-27 00:00:00 1. Hunan Muta Biotechnology Development Co., Ltd. will no longer be commissioned to produce, and the production address will be 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". |
