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进口医疗器械(注册) ——“国械注进20213020367”基本信息
Imported medical devices (registration) - basic information of "National Machinery Injection 20213020367".
注册证编号 Registration certificate number
国械注进20213020367 The national armament is injected into the 20213020367
注册人名称 Name of registrant
美国泰利福医疗有限公司 Teleflex Medical
United States Teleflex Medical
注册人住所 Domicile of the registrant
3015 Carrington Mill Blvd.,Morrisville, NC, 27560, United States
生产地址 Production address
Prolongacion Mision Eusebio Kino No.1316, Rancho El Descanso, Tecate, B.C., C.P., 21478, Mexico
Prolongación Mision Eusebio Kino No.1316, Rancho El Descanso, Tecate, B.C., C.P., 21478, Mexico
代理人名称 The name of the agent
泰利福医疗器械商贸(上海)有限公司 Teleflex Medical Device Trading (Shanghai) Co., Ltd
代理人住所 Agent's residence
中国(上海)自由贸易试验区东育路227弄6号D栋5层(实际楼层为4层)
5th Floor, Building D, No. 6, Lane 227, Dongyu Road, China (Shanghai) Pilot Free Trade Zone (the actual floor is 4 floors)
产品名称 Product name
一次性使用不可吸收结扎夹Hem-o-lok® Ligating Clips
Single-use non-absorbable ligation clips Hem-o-lok® ligating clips
管理类别 Manage categories
第三类 Category III
型号规格 Model specifications
544234, 544244, 544254
结构及组成/主要组成成分 Structure & Composition/Main Components
产品由储夹盒及盒内的结扎夹组成,每个储夹盒含有4个结扎夹。产品采用环氧乙烷灭菌,一次性使用。
The product consists of a clamp box and a ligation clip inside the box, each containing 4 ligation clips. The product is sterilized with ethylene oxide and used once.
适用范围/预期用途 Scope of application/intended use
结扎夹预期用于手术中对血管或其他管状组织结构进行结扎。结扎的血管/组织尺寸范围为:中大号3-10mm;大号5-13mm;加大号7-16mm。本产品专门设计为与Teleflex Medical的Weck® Hem-o-lok®中大号/大号/加大号施夹钳和除夹钳配合使用。
Ligation clips are intended to be used during surgery to ligate blood vessels or other tubular tissue structures. The size of ligated blood vessels/tissues ranges from: medium to large 3-10 mm; Large 5-13mm; Plus 7-16mm. This product is specifically designed for use with Teleflex Medical's Weck® Hem-o-lok® mid-large/large/plus clamps and remover pliers.
产品储存条件及有效期 Product storage conditions and expiration date
附件 annex
产品技术要求 Product technical requirements
其他内容 Miscellaneous
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备注 remark
审批部门 Approval department
国家药品监督管理局 National Medical Products Administration
批准日期 Date of approval
2021-09-13
生效日期 Effective Date
有效期至 Valid until
2026-09-12
变更情况 Changes
  • 数据反馈  Data feedback
  • 常见问题  frequently asked questions
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