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Fructosamine (FMN) control - NMPA Registration 闽械注准20242400142

Access comprehensive regulatory information for Fructosamine (FMN) control in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 闽械注准20242400142 and owned by InTec Products, INC.. The device was approved on August 08, 2024.

This page provides complete registration details including registrant information, province location (Fujian), 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
闽械注准20242400142
Fructosamine (FMN) control
果糖胺（FMN）质控品
NMPA Registration Number: 闽械注准20242400142
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Pricing
Intended Use
English

It is used in conjunction with the fructosamine kit produced by our company for in-house quality control of fructosamine detection systems.

中文

与本公司生产的果糖胺试剂盒配套使用，用于果糖胺检测系统的室内质量控制。.

Device Classification
Device Class
Class II
Model Specifications
Level 1: 1mL×1 Level 1: 1mL×3 Level 2: 1mL×1 Level 2: 1mL×3 Level 1: 1mL×1, Level 2: 1mL×1 Level 1: 1mL×3, Level 2: 1mL×3
水平1：1mL×1 水平1：1mL×3 水平2：1mL×1 水平2：1mL×3 水平1：1mL×1，水平2：1mL×1 水平1：1mL×3，水平2：1mL×3
Approval Department
Fujian Provincial Drug Administration
福建省药品监督管理局
Registration Information
Registration Number
闽械注准20242400142
Approval Date
August 08, 2024
Expiry Date
August 07, 2029
Registrant
Name
InTec Products, INC.
英科新创（厦门）科技股份有限公司
Province/Region
Fujian
福建
Address
No. 332, Xinguang Road, Xiamen Xinyang Industrial Zone, Haicang
厦门市海沧新阳工业区新光路332号
Production Facility
Production Address
厦门市海沧新阳工业区新光路332号；厦门市海沧新阳工业区翁角路308号8号和51号厂房
Structure and Composition
English

本产品是在磷酸盐缓冲液基质中添加果糖胺(糖化白蛋白)、防腐剂等制成的冻干粉. 果糖胺(糖化白蛋白)浓度范围:水平1:50μmol/L ～285μmol/L,水平2:285μmol/L ～1145μmol/L..

中文

本产品是在磷酸盐缓冲液基质中添加果糖胺（糖化白蛋白）、防腐剂等制成的冻干粉。果糖胺（糖化白蛋白）浓度范围：水平1：50μmol/L ～285μmol/L，水平2：285μmol/L ～1145μmol/L。.

Storage Conditions and Expiration
English

Store in the dark at 2°C~8°C, valid for 18 months.

中文

避光储存于2℃～8℃，有效期18个月。

Additional Information
Appendix
产品技术要求、说明书