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Disposable electric endoscope cutting stapler - NMPA Registration 京械注准20222010531

Access comprehensive regulatory information for Disposable electric endoscope cutting stapler 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20222010531 and owned by B.J.Zh.F.Panther Medical Equipment Co., Ltd.. The device was approved on December 23, 2022.

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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NMPA Official Data
Class II
京械注准20222010531
Disposable electric endoscope cutting stapler
一次性使用电动腔镜切割吻合器
NMPA Registration Number: 京械注准20222010531
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Intended Use
English

Single-use motorized laparoscopic cutting staplers are identified by the chip and used with the stapler assembly for disengagement, excision, and/or anastomosis. It is suitable for surgical anastomosis of the digestive tract and lungs.

中文

一次性使用电动腔镜切割吻合器经芯片识别后配合吻合器组件使用,可用于离断、切除和/或建立吻合。适用于消化道、肺部手术吻合用。

Device Classification
Device Class
Class II
Model Specifications
Wildcard models PEKS PEKM PEKL Dedicated models PEKS30 PEKSS30 PEKM30 PEKMM30 PEKL30 PEKLL30 PEKS45 PEKSS45 PEKM45 PEKMM45 PEKL45 PEKLL45 PEKS60 PEKSS60 PEKM60 PEKMM60 PEKL60 PEKLL60 PEKS65 PEKSS65 PEKM65 PEKMM65 PEKL65 PEKLL65
通配型号 PEKS PEKM PEKL 专配型号 PEKS30 PEKSS30 PEKM30 PEKMM30 PEKL30 PEKLL30 PEKS45 PEKSS45 PEKM45 PEKMM45 PEKL45 PEKLL45 PEKS60 PEKSS60 PEKM60 PEKMM60 PEKL60 PEKLL60 PEKS65 PEKSS65 PEKM65 PEKMM65 PEKL65 PEKLL65
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20222010531
Approval Date
December 23, 2022
Expiry Date
December 22, 2027
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,北京市昌平区科技园区火炬街28号
Structure and Composition
English

The single-use motorized laparoscopic cutting stapler consists of a host unit and a battery pack.

中文

一次性使用电动腔镜切割吻合器由主机和电池组组成。

Storage Conditions and Expiration
English

5 years

中文

5年

Additional Information
Appendix
产品技术要求