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一次性使用腹腔镜持针器 - NMPA Registration 京械注准20242020510

Access comprehensive regulatory information for 一次性使用腹腔镜持针器 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242020510 and owned by B.J.Zh.F.Panther Medical Equipment Co., Ltd.. The device was approved on September 30, 2024.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20242020510
一次性使用腹腔镜持针器
NMPA Registration Number: 京械注准20242020510
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Pricing
Intended Use
English

产品与腹腔镜配合,供腹腔手术中用于夹持缝合针、缝合线,用于缝合组织.

中文

产品与腹腔镜配合,供腹腔手术中用于夹持缝合针、缝合线,用于缝合组织。

Device Classification
Device Class
Class II
Model Specifications
LN-285-Z、LN-345-Z、LN-405-Z
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242020510
Approval Date
September 30, 2024
Expiry Date
September 29, 2029
Registrant
Name
B.J.Zh.F.Panther Medical Equipment Co., Ltd.
北京派尔特医疗科技股份有限公司
Province/Region
Beijing
北京
Address
The third floor of Building 1, No. 28 Torch Street, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区火炬街28号1号楼三层
Production Facility
Production Address
北京市昌平区北七家镇上承路8号A区、B区、C区;北京市昌平区北七
Structure and Composition
English

产品由头部、杆部和手柄组成,手柄包括基座、手环扣、传动带、拨轮、握柄、扳机、手环.产品为一次性使用,无菌提供,环氧乙烷灭菌,有效期5年.

中文

产品由头部、杆部和手柄组成,手柄包括基座、手环扣、传动带、拨轮、握柄、扳机、手环。产品为一次性使用,无菌提供,环氧乙烷灭菌,有效期5年。

Storage Conditions and Expiration
English

5 years

中文

5年

Additional Information
Changes
注册地址变更为:北京市昌平区科技园区火炬街28号1号楼三层。生产地址变更为:北京市昌平区北七家镇上承路8号A区、B区、C区;北京市昌平区北七。签发日期变更为:2024-09-30。
Appendix
产品技术要求