Pure Global

a-L-Fucosidase Detection Kit (CNPF Substrate Method) - NMPA Registration 京械注准20242400449

Access comprehensive regulatory information for a-L-Fucosidase Detection Kit (CNPF Substrate 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 京械注准20242400449 and owned by Beijing Homa Biological Engineering Co., Ltd.. The device was approved on February 04, 2025.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20242400449
a-L-Fucosidase Detection Kit (CNPF Substrate Method)
a-L-岩藻糖苷酶测定试剂盒(CNPF底物法)
NMPA Registration Number: 京械注准20242400449
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

该产品用于体外定量测定人血清中alpha;-L-岩藻糖苷酶(AFU)的活性.

中文

该产品用于体外定量测定人血清中alpha;-L-岩藻糖苷酶(AFU)的活性。

Device Classification
Device Class
Class II
Model Specifications
试剂1:1;40ml,质控品:2;1ml;试剂1:2;40ml;试剂1:1;60ml,质控品:2;1ml;试剂1:2;60ml;试剂1:6;60ml,质控品:2;1ml;试剂1:4;60ml;试剂1:6;100ml,质控品:2;1ml;试剂1:2;20ml;试剂1:1;20ml,质控品:2;1ml;试剂1:5;24ml;试剂1:1L;试剂1:5L.
试剂1:1;40ml,质控品:2;1ml;试剂1:2;40ml;试剂1:1;60ml,质控品:2;1ml;试剂1:2;60ml;试剂1:6;60ml,质控品:2;1ml;试剂1:4;60ml;试剂1:6;100ml,质控品:2;1ml;试剂1:2;20ml;试剂1:1;20ml,质控品:2;1ml;试剂1:5;24ml;试剂1:1L;试剂1:5L。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400449
Approval Date
February 04, 2025
Expiry Date
February 03, 2030
Registrant
Name
Beijing Homa Biological Engineering Co., Ltd.
北京豪迈生物工程股份有限公司
Province/Region
Beijing
北京
Address
East of the first and third floors of Building 7, No. 28 Yuhua Road, Linkong Economic Core Zone, Shunyi District, Beijing
北京市顺义区临空经济核心区裕华路28号7号楼一层、三层东侧
Production Facility
Production Address
北京市顺义区临空经济核心区裕华路28号7号楼一层、三层东侧
Structure and Composition
English

试剂1(R)组成:柠檬酸缓冲液、2-氯-4-硝基苯-a-L-岩藻吡喃糖苷、乙二胺四乙酸二钠;质控品(液体)组成:质控品(水平1):柠檬酸缓冲液、a-L-岩藻糖苷酶;质控品(水平2):柠檬酸缓冲液、a-L-岩藻糖苷酶.

中文

试剂1(R)组成:柠檬酸缓冲液、2-氯-4-硝基苯-a-L-岩藻吡喃糖苷、乙二胺四乙酸二钠;质控品(液体)组成:质控品(水平1):柠檬酸缓冲液、a-L-岩藻糖苷酶;质控品(水平2):柠檬酸缓冲液、a-L-岩藻糖苷酶。

Additional Information
Appendix
产品技术要求、说明书