Fully automatic biochemical analyzer
- 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 number
- 苏械注准20242221987
- Approval date
- October 15, 2024
- Expiry date
- October 14, 2029
- 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 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
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.
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。
The automatic biochemical analyzer is composed of automatic sample filling unit, sample processing unit, detection unit, control and data processing unit.
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。
not applicable
不适用
- Appendix
- 产品技术要求
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.