Disposable venous indwelling needle - NMPA Registration 国械注准20233140291

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20233140291 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on March 09, 2023.

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.

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NMPA Official Data

Class III

国械注准20233140291

Disposable venous indwelling needle

一次性使用静脉留置针

NMPA Registration Number: 国械注准20233140291

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Intended Use

English

This product is used for intravenous indwelling continuous infusion of patients, and the indwelling time is not more than 72 hours.

中文

本产品用于患者静脉留置连续输液，留置人体时间不大于72小时。

Device Classification

Device Class

Class III

Model Specifications

型号:普通两通型(Y-II.型)、普通三通型(Y-III.型)、无针两通型(W-II.型)和无针三通型(W-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)

型号：普通两通型(Y-Ⅱ型)、普通三通型(Y-Ⅲ型)、无针两通型(W-Ⅱ型)和无针三通型(W-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 Information

Registration Number

国械注准20233140291

Approval Date

March 09, 2023

Expiry Date

March 08, 2028

Registrant

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 Facility

Production Address

江西省南昌市进贤县城胜利南路39号

Structure and Composition

English

Disposable intravenous indwelling needle products consist of protective sleeves, catheters, metal wedges, catheter holders, isolation plugs, syringes, needle holders, water stops, hoses, hose holders (2-way and 3-way types), needleless fittings (2-way and 3-way types), heparin caps and end caps, in which the catheter is made of polyurethane (PUR) material and the inner layer of the hose is made of thermoplastic polyurethane (TPU) material. The product is sterilized with ethylene oxide and used in a single use.

中文

一次性使用静脉留置针产品由保护套、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)、肝素帽和端帽组成；其中导管采用聚氨酯（PUR）材料，软管内层采用热塑性聚氨酯（TPU）材料。产品经环氧乙烷灭菌，一次性使用。

Additional Information

Appendix

产品技术要求