Pure Global
Registrant profile

Shenzhen AmTech Bioengineering Ltd,Inc

深圳上泰生物工程有限公司
Guangdong·China NMPA·135 registered devices
135
Total devices
2
Device classes
2020
Earliest approval
2025
Latest approval
Company overview
Total devices
135
Province/Region
Guangdong
广东
Address
901, Building A1A2, Building A1, Building A1, Guangming Science and Technology Park, Phoenix Community Tourist Road, Guangming District, Shenzhen
深圳市光明区凤凰街道凤凰社区观光路招商局光明科技园A1A2栋A1栋901
Registration timeline
Earliest approval
Aug 27, 2020
Latest approval
Jan 14, 2025
Device class distribution
Breakdown of 135 devices by regulatory classification
Class II
132
97.8% of total
Class III
3
2.2% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
25-Hydroxyvitamin D (25-OH-VD) Assay Kit (Magnetic Particle Chemiluminescence Method)
25-羟基维生素D（25-OH-VD）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20252400077Jan 14, 2025Jan 13, 2030View
Tumor Antigen 50 (CA50) Test Kit (Chemiluminescent Immunoassay)
糖类抗原50（CA50）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20252400081Jan 14, 2025Jan 13, 2030View
铁蛋白(Ferr)测定试剂盒(磁微粒化学发光法)
铁蛋白（Ferr）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20242401375Oct 16, 2024Oct 15, 2029View
Vitamin B12 (VB12) Determination Reagent Kit (Chemiluminescence Method with Magnetic Microparticles)
维生素B12（VB12）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20242401376Oct 16, 2024Oct 15, 2029View
Tumor-associated antigen 242 (CA242) assay kit (chemiluminescent magnetic microparticle immunoassay)
糖类抗原242（CA242）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20242401374Oct 16, 2024Oct 15, 2029View
Gastrin-releasing peptide precursor (proGRP) assay kit (chemiluminescence immunoassay with magnetic microspheres)
胃泌素释放肽前体（proGRP）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20242401373Oct 16, 2024Oct 15, 2029View
Folic acid (FA) determination reagent kit (magnetic microparticle chemiluminescence method)
叶酸（FA）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20242401337Oct 09, 2024Oct 08, 2029View
Cancer antigen 72-4 (CA72-4) determination reagent kit (chemiluminescence method)
癌抗原72-4（CA72-4）测定试剂盒（化学发光法）
Class II粤械注准20242400532Apr 18, 2024Apr 17, 2029View
Neuron-Specific Enolase (NSE) Determination Reagent Kit (Chemiluminescence Method)
神经元特异性烯醇化酶（NSE）测定试剂盒（化学发光法）
Class II粤械注准20242400527Apr 15, 2024Apr 14, 2029View
Retinol Binding Protein (RBP) Determination Reagent Kit (Immunoturbidimetry)
视黄醇结合蛋白（RBP）测定试剂盒（免疫散射比浊法）
Class II粤械注准20242400526Apr 15, 2024Apr 14, 2029View
About this profile

Complete regulatory portfolio for Shenzhen AmTech Bioengineering Ltd,Inc in China's medical device market. This registrant has 135 medical devices registered with China NMPA, with registrations dating from Aug 27, 2020 to Jan 14, 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.