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Registrant profile

Qingdao Hightop Biotech Co., Ltd.

青岛汉唐生物科技有限公司
Shandong·China NMPA·182 registered devices
182
Total devices
2
Device classes
2017
Earliest approval
2025
Latest approval
Company overview
Total devices
182
Province/Region
Shandong
山东
Address
No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone
青岛高新技术产业开发区河东路369号
Registration timeline
Earliest approval
Feb 14, 2017
Latest approval
Jan 03, 2025
Device class distribution
Breakdown of 182 devices by regulatory classification
Class II
148
81.3% of total
Class III
34
18.7% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白联合检测试剂盒(干式免疫荧光发光法)
心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白联合检测试剂盒（干式免疫荧光发光法）
Class II鲁械注准20242401060Jan 03, 2025Dec 01, 2029View
肺炎衣原体IgG抗体检测试剂盒(免疫荧光法)
肺炎衣原体IgG抗体检测试剂盒（免疫荧光法）
Class III国械注准20243402486Dec 13, 2024Dec 12, 2029View
Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Kit (Latex-Enhanced Immuno Turbidimetric Method)
脂蛋白相关磷脂酶A2测定试剂盒（胶乳免疫比浊法）
Class II鲁械注准20242401055Dec 02, 2024Dec 01, 2029View
肺炎支原体IgM抗体检测试剂盒(免疫荧光法)
肺炎支原体IgM抗体检测试剂盒（免疫荧光法）
Class III国械注准20243402367Nov 21, 2024Nov 20, 2029View
肺炎支原体IgG抗体检测试剂盒(免疫荧光法)
肺炎支原体IgG抗体检测试剂盒（免疫荧光法）
Class III国械注准20243402368Nov 21, 2024Nov 20, 2029View
β-Hydroxybutyrate Assay Kit (β-Hydroxybutyrate Dehydrogenase Method)
β-羟丁酸测定试剂盒（β-羟丁酸脱氢酶法）
Class II鲁械注准20242401023Nov 19, 2024Nov 18, 2029View
Lipoprotein-associated phospholipase A2 assay kit (enzymatic)
脂蛋白相关磷脂酶A2测定试剂盒（酶法）
Class II鲁械注准20242400885Sep 23, 2024Sep 22, 2029View
Pepsinogen I./Pepsinogen II./Gastrin 17 Combined Detection Kit (Dry Immunofluorescence Luminescence Method)
胃蛋白酶原Ⅰ/胃蛋白酶原Ⅱ/胃泌素17联合检测试剂盒（干式免疫荧光发光法）
Class II鲁械注准20242400891Sep 23, 2024Sep 22, 2029View
Homocysteine Assay Kit (Dry Immunofluorescence Luminescence)
同型半胱氨酸检测试剂盒（干式免疫荧光发光法）
Class II鲁械注准20242400802Aug 14, 2024Aug 13, 2029View
Fully automatic fluorescence immunoassay analyzer
全自动荧光免疫分析仪
Class II鲁械注准20242220740Jul 25, 2024Jul 11, 2029View
About this profile

Complete regulatory portfolio for Qingdao Hightop Biotech Co., Ltd. in China's medical device market. This registrant has 182 medical devices registered with China NMPA, with registrations dating from Feb 14, 2017 to Jan 03, 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.