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Disposable Sterile Auxiliary Pack - NMPA Registration 鲁械注准20252140056

Access comprehensive regulatory information for Disposable Sterile Auxiliary Pack in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20252140056 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on January 28, 2025.

This page provides complete registration details including registrant information, province location (Shandong), 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
鲁械注准20252140056
Disposable Sterile Auxiliary Pack
一次性使用无菌辅助包
NMPA Registration Number: 鲁械注准20252140056
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Pricing
Intended Use
English

本产品主要适用于临床护理、抢救及治疗中的辅助检查使用。

Device Classification
Device Class
Class II
Model Specifications
ZS-FZB-A综合包、ZS-FZB-I拆线包、ZS-FZB-II口腔护理包、ZS-FZB-III透析护理包、ZS-FZB-IV PICC插管消毒包、ZS-FZB-V会阴护理包、ZS-FZB-VI胃镜检查包、FZB-VII吸痰辅助包、ZS-FZB-VIII急救包。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20252140056
Approval Date
January 28, 2025
Expiry Date
January 27, 2030
Registrant
Name
Shandong Zhushi Pharmaceutical Group Co., Ltd.
山东朱氏药业集团有限公司
Province/Region
Shandong
山东
Address
South of Fanlou Road, Shanxian Development Zone
单县开发区樊楼路南
Production Facility
Production Address
山东单县经济技术开发区食品药品产业园单德路6号
Structure and Composition
English

一次性使用无菌辅助包(以下简称辅助包)由以下配件组成: 主要配件:拆线剪、止血带、无菌棉球、医用纱布块、压舌板、灭菌橡胶外科手套、口镜、探针、洞巾、无菌阴道扩张器、消毒刷、鼻胃肠管、口垫、吸痰管、手术刀、带线缝合针、手术刀片。 辅助配件:塑料托盘(大)、塑料托盘(小)、透明塑料托盘(小)、敷料镊、一次性使用手术钳、医用检查手套、PE检查手套、包巾、医用棉签、纱布绷带、吸水纸、治疗巾、无菌敷贴、医用压敏胶带、酒精棉球、碘伏棉球、塑料碗、医用输液贴、医用中单、透气胶带。

Additional Information
Appendix
产品技术要求