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Cystatin C quality control material - NMPA Registration 鄂械注准20242405012

Access comprehensive regulatory information for Cystatin C quality control material 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20242405012 and owned by Wuhan Life Origin Biotech Joint Stock Co., Ltd.. The device was approved on June 06, 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20242405012
Cystatin C quality control material
胱抑素C质控品
NMPA Registration Number: 鄂械注准20242405012
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Pricing
Intended Use
English

该产品与本公司生产的胱抑素C测定试剂盒配套使用,用于该项目的室内质量控制。

Device Classification
Device Class
Class II
Model Specifications
0.5mL×2 (2 levels)
0.5mL×2(2水平)
Approval Department
Hubei Provincial Drug Administration
湖北省药品监督管理局
Registration Information
Registration Number
鄂械注准20242405012
Approval Date
June 06, 2024
Expiry Date
June 05, 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

2-(N-吗啡啉)乙磺酸、胱抑素C蛋白。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

本品于2℃~8℃密封避光储存,有效期为18个月。

Additional Information
Changes
无无
Appendix
产品技术要求、说明书