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Fully automatic biochemical analyzer - NMPA Registration 苏械注准20242221987

Access comprehensive regulatory information for Fully automatic biochemical 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 苏械注准20242221987 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on October 15, 2024.

This page provides complete registration details including registrant information, province location (Jiangsu), 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
苏械注准20242221987
Fully automatic biochemical analyzer
全自动生化分析仪
NMPA Registration Number: 苏械注准20242221987
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Intended Use
English

Based on the spectrophotometric principle, it is used in conjunction with the adaptation reagent. For in vitro quantitative analysis of clinical chemical components in human samples.

中文

基于分光光度原理,与适配试剂共同使用。供医疗机构体外定量分析人体样本中的临床化学成分。

Device Classification
Device Class
Class II
Model Specifications
AL1000、AL860
Approval Department
Jiangsu Provincial Drug Administration
江苏省药品监督管理局
Registration Information
Registration Number
苏械注准20242221987
Approval Date
October 15, 2024
Expiry Date
October 14, 2029
Registrant
Name
Ali Biotech Taizhou Co., Ltd.
阿里生物技术泰州有限公司
Province/Region
Jiangsu
江苏
Address
Taizhou National Pharmaceutical High-tech Industrial Park, west of Taizhou Medical City, west of Tai Road, east of Building 0007, G61, East of Lujia Road, east of the first to fourth floors
泰州国家医药高新技术产业园中国医药城口泰路西侧、陆家路东侧0007幢G61号一至四层东侧
Production Facility
Production Address
泰州中国医药城口泰路西侧、陆家路东侧0007幢61号一至四层东侧
Structure and Composition
English

The automatic biochemical analyzer is composed of automatic sample filling unit, sample processing unit, detection unit, control and data processing unit.

中文

全自动生化分析仪由自动进样单元、样品处理单元、检测单元、控制及数据处理单元组成。

Storage Conditions and Expiration
English

not applicable

中文

不适用

Additional Information
Appendix
产品技术要求