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Pulsating vacuum cleaning and disinfection machine - NMPA Registration 鲁械注准20242111064

Access comprehensive regulatory information for Pulsating vacuum cleaning and disinfection machine 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20242111064 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on December 05, 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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Class II
鲁械注准20242111064
Pulsating vacuum cleaning and disinfection machine
脉动真空清洗消毒器
NMPA Registration Number: 鲁械注准20242111064
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Intended Use
English

This product is used for cleaning, disinfection and drying of surgical instruments, minimally invasive surgical instruments, utensils and luminal instruments and heat- and moisture-resistant medical devices.

中文

该产品用于对手术器械、微创外科器械、器皿器具和管腔器械类耐热耐湿的医疗器械的清洗、消毒和干燥。

Device Classification
Device Class
Class II
Model Specifications
Pentum A:Pentum A5646、Pentum A6646、Pentum A6656、Pentum A6966; Pentum S:Pentum S6456.
Pentum A:Pentum A5646、Pentum A6646、Pentum A6656、Pentum A6966; Pentum S:Pentum S6456。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242111064
Approval Date
December 05, 2024
Expiry Date
December 04, 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

该产品主要由舱体、支架、密封门、管路、外罩及控制系统组成.

中文

该产品主要由舱体、支架、密封门、管路、外罩及控制系统组成。

Additional Information
Appendix
产品技术要求