Pure Global

Glycated hemoglobin quality control material - NMPA Registration 粤械注准20252400162

Access comprehensive regulatory information for Glycated hemoglobin 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 粤械注准20252400162 and owned by Shenzhen Lifotronic Technology Co., Ltd.. The device was approved on January 24, 2025.

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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
粤械注准20252400162
Glycated hemoglobin quality control material
糖化血红蛋白质控品
NMPA Registration Number: 粤械注准20252400162
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

与深圳普门科技股份有限公司的糖化血红蛋白(HbA1c)测定试剂盒(高效液相色谱法)、糖化血红蛋白(HbA1c)测定试剂盒(液相色谱离子交换层析法)、糖化血红蛋白(HbA1c)分析用洗脱液(高效液相色谱法)、或糖化血红蛋白测定试剂盒(高效液相色谱法)配合使用,用于人全血中糖化血红蛋白(HbA1c)项目检测时的室内质量控制。

Device Classification
Device Class
Class II
Model Specifications
2×0.1mL/盒,2×0.3mL/盒,2×0.5mL/盒(内含水平1、水平2)
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20252400162
Approval Date
January 24, 2025
Expiry Date
January 23, 2030
Registrant
Name
Shenzhen Lifotronic Technology Co., Ltd.
深圳普门科技股份有限公司
Province/Region
Guangdong
广东
Address
Pumen Science and Technology Headquarters Building, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen
深圳市龙华区观湖街道观城社区求知东路8号普门科技总部大厦
Production Facility
Production Address
广东省东莞市松山湖园区彰化路2号1号厂房2-11楼(委托生产)
Structure and Composition
English

主要由糖化血红蛋白(人全血)、硫酸庆大霉素(防腐剂)组成。

Storage Conditions and Expiration
English

1、2~8℃避光储存,有效期24个月。 2、本品开瓶复溶分装后,储存于-20℃条件下的稳定期为30天,仅可冻融1次。

Additional Information
Remark
受托生产企业:广东普门生物医疗科技有限公司;统一社会信用代码:91441900MA4UHLWH4C。
Appendix
产品技术要求、说明书