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Legacy registrant archive

Medicalsystem Biotechnology Co., Ltd.

美康生物科技股份有限公司
chekiangChina NMPA263 archived records
Static archiveNMPA · legacy registration snapshot
263
Archived records
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Archived records
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
Regulatory footprint
Search Medicalsystem Biotechnology Co., Ltd. across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Device class distribution
Breakdown of 263 devices by regulatory classification
Class II24492.8% of total
Class III197.2% of total
Archived records (10 most recent shown)
Click on any device for detailed registration information
Antithrombin III Determination Test Kit (Chromogenic Substrate Method)
抗凝血酶Ⅲ检测试剂盒（发色底物法）
Jan 06, 2025
Registration number
浙械注准20252401010
Class
Class II
Expiry date
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）
Dec 24, 2024
Registration number
浙械注准20242402088
Class
Class II
Expiry date
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）
Dec 24, 2024
Registration number
浙械注准20242402089
Class
Class II
Expiry date
Dec 23, 2029
Prothrombin time test kit (coagulation method)
凝血酶原时间检测试剂盒（凝固法）
Dec 13, 2024
Registration number
浙械注准20242402068
Class
Class II
Expiry date
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）
Dec 13, 2024
Registration number
浙械注准20242402045
Class
Class II
Expiry date
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）
Dec 13, 2024
Registration number
浙械注准20242402070
Class
Class II
Expiry date
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）
Dec 13, 2024
Registration number
国械注准20243402495
Class
Class III
Expiry date
Dec 12, 2029
Coagulation multiple quality control product
凝血多项质控品
Dec 13, 2024
Registration number
浙械注准20242402066
Class
Class II
Expiry date
Dec 12, 2029
Thrombin Time Test Kit (Coagulation Method)
凝血酶时间检测试剂盒（凝固法）
Nov 03, 2024
Registration number
浙械注准20242401953
Class
Class II
Expiry date
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）
Oct 25, 2024
Registration number
浙械注准20242401931
Class
Class II
Expiry date
Oct 24, 2029
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About this profile

This static archive contains 263 records under the historical name Medicalsystem Biotechnology Co., Ltd.. It does not establish the company's complete current portfolio or current authorization status.

Historical English translations and official Chinese names can differ. These archived names are not automatically equated with a holder in the current domestic-registration listing.