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Registrant profile

Suzhou Lihe Biomedical Engineering Co., Ltd.

苏州立禾生物医学工程有限公司
Jiangsu·China NMPA·205 registered devices
205
Total devices
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Total devices
205
Province/Region
Jiangsu
江苏
Address
Room 501, Building B11, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park
苏州工业园区星湖街218号生物纳米园B11号楼501室
Registration timeline
Earliest approval
Jul 30, 2019
Latest approval
Feb 07, 2025
Device class distribution
Breakdown of 205 devices by regulatory classification
Class II
176
85.9% of total
Class III
29
14.1% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
抗甲状腺微粒体抗体测定试剂盒（化学发光免疫分析法）
Class II苏械注准20252400195Feb 07, 2025Feb 06, 2030View
Fully automatic biochemical analyzer
全自动生化分析仪
Class II苏械注准20242222132Jan 15, 2025Nov 07, 2029View
High-sensitivity Troponin I Assay Kit (Chemiluminescence Immunoassay)
高敏肌钙蛋白I测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242402239Nov 27, 2024Nov 26, 2029View
Thrombomodulin Detection Kit (Chemiluminescent Immunoassay Method)
血栓调节蛋白测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242402224Nov 27, 2024Nov 26, 2029View
Thrombin-Antithrombin III Complex Test Kit (Chemiluminescence Immunoassay)
凝血酶-抗凝血酶Ⅲ复合物测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242402182Nov 22, 2024Nov 21, 2029View
α-干扰素检测试剂盒（化学发光免疫分析法）
Class II苏械注准20242402025Oct 21, 2024Oct 20, 2029View
γ-Interferon Detection Kit (Chemiluminescence Immunoassay)
γ-干扰素检测试剂盒（化学发光免疫分析法）
Class II苏械注准20242401939Sep 29, 2024Sep 28, 2029View
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
Class II苏械注准20242220364Mar 13, 2024Mar 12, 2029View
Tumor-Associated Antigen 242 Determination Reagent Kit (Chemiluminescence Immunoassay)
肿瘤相关抗原242测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242400348Mar 12, 2024Aug 25, 2029View
Carcinoembryonic antigen assay kit (chemiluminescence immunoassay)
癌胚抗原测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242400352Mar 12, 2024Aug 25, 2029View
About this profile

Complete regulatory portfolio for Suzhou Lihe Biomedical Engineering Co., Ltd. in China's medical device market. This registrant has 205 medical devices registered with China NMPA, with registrations dating from Jul 30, 2019 to Feb 07, 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.