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Sodium Assay Reagent Kit (Galactosidase Method) - NMPA Registration 冀械注准20142400346

Access comprehensive regulatory information for Sodium Assay Reagent Kit (Galactosidase Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 冀械注准20142400346 and owned by Langfang Hengyi Biotechnology Co., Ltd.. The device was approved on November 07, 2019.

This page provides complete registration details including registrant information, province location (Hebei), 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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Class II
冀械注准20142400346
Sodium Assay Reagent Kit (Galactosidase Method)
钠测定试剂盒(半乳糖苷酶法)
NMPA Registration Number: 冀械注准20142400346
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Intended Use
English

It is used for the quantitative determination of sodium content in human serum in vitro.

中文

用于体外定量测定人体血清中钠的含量。

Device Classification
Device Class
Class II
Approval Department
Hebei Food and Drug Administration
河北省食品药品监督管理局
Registration Information
Registration Number
冀械注准20142400346
Approval Date
November 07, 2019
Expiry Date
November 06, 2024
Registrant
Name
Langfang Hengyi Biotechnology Co., Ltd.
廊坊恒益生物技术有限公司
Province/Region
Hebei
河北
Address
No. 1, Yilan Road, Yongqing Taiwan New Industrial City, Langfang City, Hebei Province
河北省廊坊市永清台湾工业新城宜兰道1号
Production Facility
Production Address
河北省廊坊市永清台湾工业新城宜兰道1号
Structure and Composition
English

Reagent 1: magnesium ion, 9mmol/L; O-Nitrophenol-β-galactopyranose, 19.7 mmol/L. Reagent 2: β-galactosidase, 88.5 mmol/L

中文

试剂1:镁离子,9mmol/L;O-硝基酚-β-吡喃半乳糖,19.7mmol/L。试剂2:β-半乳糖苷酶,88.5mmol/L