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Steam sterilizer - NMPA Registration 鲁械注准20242110941

Access comprehensive regulatory information for Steam sterilizer 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20242110941 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on October 20, 2024.

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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NMPA Official Data
Class II
鲁械注准20242110941
Steam sterilizer
蒸汽灭菌器
NMPA Registration Number: 鲁械注准20242110941
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Pricing
Intended Use
English

用于耐热耐湿医疗器械的灭菌.

中文

用于耐热耐湿医疗器械的灭菌。

Device Classification
Device Class
Class II
Model Specifications
MK-A:MK-A448、MK-A667、MK-A669、MK-A6911、MK-A6914、MK-A6918、MK-A61115、MK-A61118、MK-A61125 MK-H:MK-H61113、MK-H61115、MK-H61118、MK-H61125
MK-A:MK-A448、MK-A667、MK-A669、MK-A6911、MK-A6914、MK-A6918、MK-A61115、MK-A61118、MK-A61125 MK-H:MK-H61113、MK-H61115、MK-H61118、MK-H61125
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242110941
Approval Date
October 20, 2024
Expiry Date
October 19, 2029
Registrant
Name
Shinva Medical Instrument Co., Ltd.
山东新华医疗器械股份有限公司
Province/Region
Shandong
山东
Address
Xinhua Medical Science and Technology Park, Zibo High-tech Industrial Development Zone, Shandong Province
山东省淄博市高新技术产业开发区新华医疗科技园
Production Facility
Production Address
淄博市周村区新华大道2009号
Structure and Composition
English

蒸汽灭菌器主要由柜体、柜门、消毒车、搬运车、加热系统(仅限自带蒸汽发生器的设备)、管路系统和控制系统组成.

中文

蒸汽灭菌器主要由柜体、柜门、消毒车、搬运车、加热系统(仅限自带蒸汽发生器的设备)、管路系统和控制系统组成。

Additional Information
Appendix
产品技术要求