Disposable arterial and venous puncture needle
- Device class
- Class III
- Model specifications
- 型 号：固定翼 NP-P、固定翼 NP-S、旋转翼 NP-P、旋转翼 NP-S规 格：1.4(17G)、1.6(16G)、1.8(15G)、2.1(14G)
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243102589
- Approval date
- January 23, 2025
- Expiry date
- December 15, 2029
- 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
This product is used for vascular puncture during clinical hemodialysis.
本产品用于临床上血液透析时的血管穿刺。
一次性使用动静脉穿刺针由针管保护套、针管、针柄、软管、防针刺保护装置、止水夹、内圆锥接头和接头保护套组成，其中防针刺保护装置为可选配件。原材料包括聚丙烯、不锈钢SUS304、聚氯乙烯（TOTM增塑剂）、丙烯腈-丁二烯-苯乙烯共聚物、聚乙烯。产品经环氧乙烷灭菌。一次性使用。
- Remark
- 2025年1月23日同意更正结构及组成相关内容，2024年12月16日核发的中华人民共和国医疗器械注册证予以废止。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Disposable arterial and venous puncture 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20243102589 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on January 23, 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.