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Disposable sterile radial artery hemostat - NMPA Registration 鲁械注准20242140867

Access comprehensive regulatory information for Disposable sterile radial artery hemostat in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242140867 and owned by Shandong Weigao Group MEDICAL Polymer Co., Ltd.. The device was approved on September 12, 2024.

This page provides complete registration details including registrant information, province location (Shandong), 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 II
鲁械注准20242140867
Disposable sterile radial artery hemostat
一次性使用桡动脉压迫止血器
NMPA Registration Number: 鲁械注准20242140867
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Intended Use
English

It is suitable for patients with radial artery catheter intubation and postoperative compression hemostasis.

中文

适用于患者桡动脉导管插管术后压迫止血。

Device Classification
Device Class
Class II
Model Specifications
一次性使用桡动脉压迫止血器型号分为A型和B型,按其功能及配置不同分为:ZXQ-A0000、ZXQ-A0100、ZXQ-A1000、ZXQ-A1100、ZXQ-A0001、ZXQ-A0101、ZXQ-A1001、ZXQ-A1101、ZXQ-A0010、ZXQ-A0110、ZXQ-A1010、ZXQ-A1110、ZXQ-A0011、ZXQ-A0111、ZXQ-A1011、ZXQ-A1111、ZXQ-B0000、ZXQ-B0100,共18种规格.
一次性使用桡动脉压迫止血器型号分为A型和B型,按其功能及配置不同分为:ZXQ-A0000、ZXQ-A0100、ZXQ-A1000、ZXQ-A1100、ZXQ-A0001、ZXQ-A0101、ZXQ-A1001、ZXQ-A1101、ZXQ-A0010、ZXQ-A0110、ZXQ-A1010、ZXQ-A1110、ZXQ-A0011、ZXQ-A0111、ZXQ-A1011、ZXQ-A1111、ZXQ-B0000、ZXQ-B0100,共18种规格。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242140867
Approval Date
September 12, 2024
Expiry Date
September 11, 2029
Registrant
Name
Shandong Weigao Group MEDICAL Polymer Co., Ltd.
山东威高集团医用高分子制品股份有限公司
Province/Region
Shandong
山东
Address
No. 1, Weigao Road, Weihai Torch High-tech Industrial Development Zone, Shandong Province
山东省威海火炬高技术产业开发区威高路1号
Production Facility
Production Address
山东省威海火炬高技术产业开发区威高路1-1号
Structure and Composition
English

The type A hemostat is composed of a gusset, a wrist strap, a compression balloon, a one-way valve, an inflatable device (with or without), an inflatable pipeline, an indicator capsule (with or without), an inflatable extension line (with or without), and a wound dressing patch (with or without). The type B hemostat is composed of a gusset, a wrist strap, a fixing pad, a compression pad, a nut, a bolt, a limiting piece, and a wound dressing (optional).

中文

A型止血器由扣板、腕带、压迫气囊、单向阀、充气装置(可不带)、充气管路、指示囊(可不带)、充气延长管路(可不带)、伤口敷料贴(可不带)构成。B型止血器由扣板、腕带、固定垫、压迫垫、螺母、螺栓、限位片、伤口敷料贴(可不带)构成。

Additional Information
Appendix
产品技术要求