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Fully automatic coagulation analyzer - NMPA Registration 粤械注准20182220629

Access comprehensive regulatory information for Fully automatic coagulation 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 粤械注准20182220629 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on November 18, 2022.

This page provides complete registration details including registrant information, province location (Guangdong), 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
粤械注准20182220629
Fully automatic coagulation analyzer
全自动凝血分析仪
NMPA Registration Number: 粤械注准20182220629
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Pricing
Intended Use
English

The analyzer uses coagulation method, chromogenic substrate method and immunoturbidimetric method for the time and activity of coagulation factors, anticoagulant proteins, fibrinolytic systems and circulating anticoagulant substances in clinical coagulation tests.

中文

该分析仪采用凝固法、发色底物法和免疫比浊法,供临床凝血检验中的凝血因子、抗凝蛋白、纤溶系统与循环抗凝物质的时间和活性检验用。

Device Classification
Device Class
Class II
Model Specifications
RAC-2800、RAC-2820、RAC-2830、RAC-2860、RAC-2890.
RAC-2800、RAC-2820、RAC-2830、RAC-2860、RAC-2890。
Approval Department
Guangdong Food and Drug Administration
广东省食品药品监督管理局
Registration Information
Registration Number
粤械注准20182220629
Approval Date
November 18, 2022
Expiry Date
June 03, 2028
Registrant
Name
Rayto Life and Analytical Sciences Co., Ltd.
深圳雷杜生命科学股份有限公司
Province/Region
Guangdong
广东
Address
The second floor of Building 5, Software Park, No. 2, Gaoxin Zhongsan Road, Yuehai Street, Nanshan District, Shenzhen
深圳市南山区粤海街道高新中三道二号软件园五号楼二层
Production Facility
Production Address
深圳市光明新区高新东片区双明大道南侧雷杜工业大厦
Structure and Composition
English

It is composed of dosing and transmission system, constant temperature system, measurement system, cleaning system and computer control part.

中文

由加样与传动系统、恒温系统、测定系统、清洗系统及计算机控制部分组成。

Storage Conditions and Expiration
English

03-JUN-28

Additional Information
Remark
原产品注册证号:粤械注准20182400629。