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Registrant profile

Medicalsystem Biotechnology Co., Ltd.

美康生物科技股份有限公司
chekiang·China NMPA·263 registered devices
263
Total devices
2
Device classes
2019
Earliest approval
2025
Latest approval
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
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20252401010Jan 06, 2025Jan 05, 2030View
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20242402088Dec 24, 2024Dec 23, 2029View
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20242402089Dec 24, 2024Dec 23, 2029View
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20242402068Dec 13, 2024Dec 12, 2029View
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20242402045Dec 13, 2024Dec 12, 2029View
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20242402070Dec 13, 2024Dec 12, 2029View
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20243402495Dec 13, 2024Dec 12, 2029View
Coagulation multiple quality control product
凝血多项质控品
Class II浙械注准20242402066Dec 13, 2024Dec 12, 2029View
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20242401953Nov 03, 2024Nov 02, 2029View
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20242401931Oct 25, 2024Oct 24, 2029View
About this profile

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.