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超声引导神经阻滞麻醉穿刺针 - NMPA Registration 国械注准20243082067

Access comprehensive regulatory information for 超声引导神经阻滞麻醉穿刺针 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20243082067 and owned by Well Lead Medical Co., Ltd.. The device was approved on November 18, 2024.

This page provides complete registration details including registrant information, province location (Guangdong), 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20243082067
超声引导神经阻滞麻醉穿刺针
NMPA Registration Number: 国械注准20243082067
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Pricing
Intended Use
English

超声引导神经阻滞麻醉穿刺针用于对人体进行穿刺,利用超声将针尖引导到目标部位神经区域的准确位置后注射药物,以进行外周神经或神经丛阻滞麻醉.

中文

超声引导神经阻滞麻醉穿刺针用于对人体进行穿刺,利用超声将针尖引导到目标部位神经区域的准确位置后注射药物,以进行外周神经或神经丛阻滞麻醉。

Device Classification
Device Class
Class III
Model Specifications
型号:AN-N ;规格:0.7×50、0.7×90、0.7×120、0.8×50、0.8×90、0.8×120、0.9×50、0.9×90、0.9×120、1.2×50、1.2×90、1.2×120.
型号:AN-N ;规格:0.7×50、0.7×90、0.7×120、0.8×50、0.8×90、0.8×120、0.9×50、0.9×90、0.9×120、1.2×50、1.2×90、1.2×120。
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243082067
Approval Date
November 18, 2024
Expiry Date
October 16, 2029
Registrant
Name
Well Lead Medical Co., Ltd.
广州维力医疗器械股份有限公司
Province/Region
Guangdong
广东
Address
No. 4, Area C, Jinhu Industrial City, Hualong Town, Panyu District, Guangzhou
广州市番禺区化龙镇金湖工业城C区4号
Production Facility
Production Address
地址1:广州市番禺区化龙镇金湖工业城C区4号,地址2:广州市番禺区化龙镇国贸大道南45号、47号
Structure and Composition
English

超声引导神经阻滞麻醉穿刺针由针管、刻度定位环、针座、保护套、延长管和盖帽等组成.针管表面有超声回声增强点.产品经环氧乙烷灭菌,一次性使用.

中文

超声引导神经阻滞麻醉穿刺针由针管、刻度定位环、针座、保护套、延长管和盖帽等组成。针管表面有超声回声增强点。产品经环氧乙烷灭菌,一次性使用。

Additional Information
Remark
2024年11月18日同意更正适用范围相关内容,2024年10月17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