Disposable Light-shielded Venous Indwelling Needle
- Device class
- Class III
- Model specifications
- 型号：普通两通型(BY-Ⅱ型)、普通三通型(BY-Ⅲ型)、无针两通型(BW-Ⅱ型)、无针三通型(BW-Ⅲ型)。规格：0.6×16mm(26G×0.63IN)、0.6×19mm(26G×0.75IN)、0.75×16mm(24G× 0.63IN) 、0.75 × 19mm(24G × 0.75IN) 、0.9 × 19mm(22G × 0.75IN) 、0.9 ×25mm(22G×1.00IN)、1.1×25mm(20G×1.00IN)、1.1×30mm(20G×1.18IN)、1.1×40mm(20G×1.57IN)、1.1×48mm(20G×1.88IN)、1.3×30mm(18G×1.18IN)、1.3×40mm(18G×1.57IN)、1.3×48mm(18G×1.88IN)。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253140270
- Approval date
- January 26, 2025
- Expiry date
- January 25, 2030
- Name
- Jiangxi HONGDA MEDICAL Equipment Group Ltd.江西洪达医疗器械集团有限公司
- Province/Region
- Jiangxi江西
- Address
- No. 39, Shengli South Road, Jinxian County, Nanchang City, Jiangxi Province江西省南昌市进贤县城胜利南路39号
- Production address
- 江西省南昌市进贤县城胜利南路39 号
本产品用于患者静脉留置连续输液，可输注光敏性药物氟尿嘧啶注射液、盐酸多巴胺注射液、维生素C 注射液、注射用亚叶酸钙、注射用硝普钠，避光范围290nm~450nm，留置人体时间不大于72 小时。
产品由保护套、导管、金属楔、导管座、隔离塞、针管、针座、止水夹、软管、软管座(两通型和三通型)、无针接头(两通型和三通型)、肝素帽、端帽、可穿刺端帽组成。软管内层材质为热塑性聚氨酯（TPU），外层材质为DEHP 增塑的聚氯乙烯（PVC），外层为避光层，避光剂为氧化铁（Fe2O3）。产品经环氧乙烷灭菌，一次性使用。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Disposable Light-shielded Venous Indwelling Needle in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253140270 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on January 26, 2025.
This page provides complete registration details including registrant information, province location (Jiangxi), 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.