Single-use suture change kit
- Device class
- Class II
- Model specifications
- Type I, Type III型、II型
- Approval department
- Henan Provincial Drug Administration河南省药品监督管理局
- Registration number
- 豫械注准20172020475
- Approval date
- August 10, 2022
- Expiry date
- August 09, 2027
- Name
- SHENGGUANG MEDICAL Instrument Co., Ltd.圣光医用制品股份有限公司
- Province/Region
- Henan河南
- Address
- East section of Longshan Avenue, Hao County郏县龙山大道东段
- Production address
- 平顶山市郏县龙山大道东段；潢川县工业大道西八路东侧
It is used for clinical surgical suturing and dressing change in medical institutions.
供医疗机构临床外科手术缝合、换药时使用。
Type I of this product is composed of suture needle and suture thread; Type II consists of suture needles, sutures, tweezers and optional components: cotton balls, gauze blocks, rubber surgical gloves, rubber examination gloves, PE gloves, hole towels, wrapping cloths, alcohol cotton balls, iodophor cotton balls, pads, tongue depressors, plastic handle scalpels, scissors, hemostats, trays, small square plates.
本产品Ⅰ型由缝合针、缝合线组成；Ⅱ型由缝合针、缝合线、镊子和选配组件：棉球、纱布块、橡胶外科手套、橡胶检查手套、PE手套、洞巾、包布、酒精棉球、碘伏棉球、垫单、压舌板、塑柄手术刀、剪刀、止血钳、托盘、小方盘组成。
Access comprehensive regulatory information for Single-use suture change kit in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20172020475 and owned by SHENGGUANG MEDICAL Instrument Co., Ltd.. The device was approved on August 10, 2022.
This page provides complete registration details including registrant information, province location (Henan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.