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Medicalsystem Biotechnology Co., Ltd.

美康生物科技股份有限公司

Complete regulatory portfolio for Medicalsystem Biotechnology Co., Ltd. in China's medical device market. This registrant has 263 medical devices registered with China NMPA, with registrations dating from Feb 22, 2019 to Jan 06, 2025.

Browse the complete device portfolio including device classifications, registration numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive China NMPA registration data, helping global MedTech companies analyze market presence and regulatory compliance for Chinese medical device manufacturers.

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NMPA Official Data
263 Devices
Company Overview
Total Devices
263
Province/Region
chekiang
浙江
Address
No. 299, Qiming South Road, Yinzhou District, Ningbo
宁波市鄞州区启明南路299号
Registration Timeline
Earliest Approval
Feb 22, 2019
Latest Approval
Jan 06, 2025
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Device Class Distribution
Breakdown of 263 devices by regulatory classification
Class II
244
92.8% of total
Class III
19
7.2% of total
Registered Devices (10 most recent shown)
Click on any device for detailed registration information
Product NameClassRegistration NumberApproval DateExpiry DateDetail
Antithrombin III Determination Test Kit (Chromogenic Substrate Method)
抗凝血酶Ⅲ检测试剂盒(发色底物法)
Class II
浙械注准20252401010
Jan 06, 2025
Jan 05, 2030
骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法)
骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法)
Class II
浙械注准20242402088
Dec 24, 2024
Dec 23, 2029
β-胶原降解产物检测试剂盒(化学发光微粒子免疫检测法)
β-胶原降解产物检测试剂盒(化学发光微粒子免疫检测法)
Class II
浙械注准20242402089
Dec 24, 2024
Dec 23, 2029
Prothrombin time test kit (coagulation method)
凝血酶原时间检测试剂盒(凝固法)
Class II
浙械注准20242402068
Dec 13, 2024
Dec 12, 2029
抗脱氧核糖核酸酶B检测试剂盒(胶乳免疫比浊法)
抗脱氧核糖核酸酶B检测试剂盒(胶乳免疫比浊法)
Class II
浙械注准20242402045
Dec 13, 2024
Dec 12, 2029
纤维蛋白溶酶原检测试剂盒(发色底物法)
纤维蛋白溶酶原检测试剂盒(发色底物法)
Class II
浙械注准20242402070
Dec 13, 2024
Dec 12, 2029
异常凝血酶原(PIVKA-Ⅱ)检测试剂盒(化学发光免疫分析法)
异常凝血酶原(PIVKA-Ⅱ)检测试剂盒(化学发光免疫分析法)
Class III
国械注准20243402495
Dec 13, 2024
Dec 12, 2029
Coagulation multiple quality control product
凝血多项质控品
Class II
浙械注准20242402066
Dec 13, 2024
Dec 12, 2029
Thrombin Time Test Kit (Coagulation Method)
凝血酶时间检测试剂盒(凝固法)
Class II
浙械注准20242401953
Nov 03, 2024
Nov 02, 2029
抗甲状腺微粒体抗体检测试剂盒(化学发光微粒子免疫检测法)
抗甲状腺微粒体抗体检测试剂盒(化学发光微粒子免疫检测法)
Class II
浙械注准20242401931
Oct 25, 2024
Oct 24, 2029