注册证编号 Registration certificate number
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".
Imported medical devices (registration) - basic information of "National Machinery Injection 20213020367".
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 | / |
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 | |
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