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Creatinine calibration product - NMPA Registration 鄂械注准20242405096

Access comprehensive regulatory information for Creatinine calibration product in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鄂械注准20242405096 and owned by Wuhan Life Origin Biotech Joint Stock Co., Ltd.. The device was approved on July 25, 2024.

This page provides complete registration details including registrant information, province location (Hubei), 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
鄂械注准20242405096
Creatinine calibration product
肌酐校准品
NMPA Registration Number: 鄂械注准20242405096
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Pricing
Intended Use
English

This product is used with the creatinine measurement kit produced by our company for the system calibration of the quantitative detection of creatinine items in clinical laboratory laboratories.

中文

该产品与本公司生产的肌酐测定试剂盒配套使用,用于临床检验实验室肌酐项目定量检测的系统校准。

Device Classification
Device Class
Class II
Model Specifications
1.0mL×1
Approval Department
Hubei Provincial Drug Administration
湖北省药品监督管理局
Registration Information
Registration Number
鄂械注准20242405096
Approval Date
July 25, 2024
Expiry Date
July 24, 2029
Registrant
Name
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
武汉生之源生物科技股份有限公司
Province/Region
Hubei
湖北
Address
1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park
武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、2楼、3楼
Production Facility
Production Address
武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、3楼
Structure and Composition
English

Pure creatinine, concentrated hydrochloric acid. (Please refer to the product manual for details)

中文

肌酐纯品、浓盐酸。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

This product is sealed and stored at 2°C~8°C and protected from light, and the expiration date is 12 months.

中文

本品于2℃~8℃密封避光储存,有效期为12个月。

Additional Information
Appendix
产品技术要求、说明书