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Disposable venous indwelling needle - NMPA Registration 国械注准20243141376

Access comprehensive regulatory information for Disposable 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20243141376 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on July 30, 2024.

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.

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Class III
国械注准20243141376
Disposable venous indwelling needle
一次性使用静脉留置针
NMPA Registration Number: 国械注准20243141376
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Intended Use
English

This product is suitable for continuous infusion of patients with peripheral intravenous indwelling, and the indwelling time does not exceed 72 hours.

中文

本产品适用于患者外周静脉留置连续输液用,留置时间不超过72小时。

Device Classification
Device Class
Class III
Model Specifications
Model: Y-type two-way, Y-type three-way Specifications: 16G, 18G, 20G, 22G, 24G, 26G
型号:Y式二通、Y式三通 规格:16G、18G、20G、22G、24G、26G
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243141376
Approval Date
July 30, 2024
Expiry Date
July 29, 2029
Registrant
Name
Henan Tuoren BEST MEDICAL Device Co., Ltd.
河南驼人贝斯特医疗器械有限公司
Province/Region
Henan
河南
Address
Changyuan City Nanpu Street Office Weiqi Road Middle Road South
长垣市南蒲街道办事处纬七路中段路南
Production Facility
Production Address
长垣市满村工业区
Structure and Composition
English

This product is composed of a heparin cap, tee/tee, stop clamp, connecting tube, anti-spill plug, hose holder, rivet, steel needle, hose, sheath, needle holder, and white cap. The main components of the product, rivets and steel needles are made of stainless steel SUS304 material, the hose is made of PTFE material, the connecting pipe is made of polyvinyl chloride material, and the plasticizer used is cyclohexane-1,2-dicarboxylic acid diethylhexyl ester (DEHCH).

中文

本产品由肝素帽、三通/二通、止流夹、连接管、防溢塞、软管座、铆钉、钢针、软管、护套、针座、白帽组成。该产品的主要组件铆钉、钢针由不锈钢SUS304材料制成,软管由聚四氟乙烯材料制成,连接管由聚氯乙烯材料制成,所用增塑剂为环己烷-1,2-二羧酸二异辛酯(DEHCH)。

Additional Information
Appendix
产品技术要求