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Electrolyte analyzer - NMPA Registration 鲁械注准20222221121

Access comprehensive regulatory information for Electrolyte analyzer 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20222221121 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on September 13, 2022.

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20222221121
Electrolyte analyzer
电解质分析仪
NMPA Registration Number: 鲁械注准20222221121
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Pricing
Intended Use
English

The electrolyte analyzer is used in conjunction with our electrolyte analyzer supporting reagent (ion selective electrode method) to quantitatively detect the concentration and pH of Na+, K+, Cl-, Ca2+ in human serum and plasma by ion selective (indirect) electrode method.

中文

电解质分析仪与我司电解质分析仪配套试剂(离子选择电极法)联合使用,用于通过离子选择(间接)电极法来定量检测人体血清和血浆中Na+、K+、Cl-、Ca2+的浓度及pH值。

Device Classification
Device Class
Class II
Model Specifications
BKE-A、BKE-B、BKE-C、BKE-D.
BKE-A、BKE-B、BKE-C、BKE-D。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20222221121
Approval Date
September 13, 2022
Expiry Date
September 12, 2027
Registrant
Name
Biobase Biodustry (Shandong) Co., Ltd.
山东博科生物产业有限公司
Province/Region
Shandong
山东
Address
Minshui Economic Development Zone, Zhangqiu District, Jinan City, Shandong Province (Shandong Brocade Industrial Park, junction of Shidong Road and Mingbu Road)
山东省济南市章丘区明水经济开发区(经十东路与明埠路交界山东博科产业园)
Production Facility
Production Address
济南市工业南路 51 号、济南市历城区港兴路 9 号博科集团总部(2 号楼二、三楼以及 3 号楼一楼)
Structure and Composition
English

The product consists of electrode module, measurement module, pipeline module, circuit module and data output module.

中文

该产品由电极模块、测量模块、管路模块、电路模块和数据输出模块组成。