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China NMPA legacy archive 粤械注准20252400160

Glycated hemoglobin calibration solution

糖化血红蛋白校准品
Shenzhen Lifotronic Technology Co., Ltd.Class IINMPAApproved January 24, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
2×0.1mL/盒
Approval department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
Registration number
粤械注准20252400160
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）
Intended use
English

Calibration of glycated hemoglobin measurement systems in clinical testing.

中文

用于临床检验中糖化血红蛋白测量系统的校准。

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、复溶后应尽快使用，复溶后可在2～8℃可保存24小时，不可冻融。

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
About this record

This static archive preserves historical registration fields and translations for Glycated hemoglobin calibration solution, registration 粤械注准20252400160. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.