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Shenzhen AmTech Bioengineering Ltd., Inc.

China·CN-MF-000043067

Last updated June 8, 2026

Information

Country
China
Address
Room 901&1001&1101, Building A1, Building A1A2, China Merchants Guangming Science Park, Guanguang Road, Fenghuang Community, Fenghuang Street,Guangming District, Shenzhen, China
Website
amtechbe.com
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
bo Zhou
EUDAMED SRN
CN-MF-000043067
FDA FEI Number
—
DUNS Number
—

Catalogue (119)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
Procalcitonin (PCT) Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Retinol Binding Protein(RBP)Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
D-Dimer Assay Kit(Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
α1-Microglobulin (α1-MG) Assay Kit (Immunonephelometric Method) R1: 2×30 mL, R2: 1×11 mL
EUDAMED
IVD GeneralActive
Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Low-Density Lipoprotein Cholesterol (LDL-C) Assay Kit (Direct Method - Surfactant Removal Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Apolipoprotein E (ApoE)Assay Kit (Immunoturbidimetric Method) R1: 2×45 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Erythrocyte Osmotic Fragility (EOF) Assay Kit (One-Tube Method) Solution A: 60 mL, Solution B: 60 mL
EUDAMED
IVD GeneralActive
α2-Macroglobulin ( α2-MG ) Assay Kit (Immunonephelometric Method) R1: 2×40 mL, R2: 1×16 mL
EUDAMED
IVD GeneralActive
Pepsinogen Ⅰ(PGⅠ) Assay Kit (Latex Immunoturbidimetric Method) R1: 2×54 mL, R2: 2×10 mL
EUDAMED
IVD GeneralActive
Retinol Binding Protein (RBP) Assay Kit (Immunonephelometric Method) R1: 2×30 mL, R2: 1×10 mL
EUDAMED
IVD GeneralActive
Lambda Light Chains (λ-LC) Assay Kit(Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Full-Range C-Reactive Protein (fCRP) Assay Kit (Latex Immunoturbidimetric Method) R1: 1×16 mL, R2: 1×8 mL
EUDAMED
IVD GeneralActive
Adenosine Deaminase (ADA) Assay Kit (Peroxidase Method) R1: 2×40 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Serum Amyloid A Protein (SAA) Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Urinary Total Protein (UTP) Assay Kit (Pyrogallol Red Molybdenum Method) R: 2×60 mL
EUDAMED
IVD GeneralActive
Aspartate Aminotransferase (AST) Assay Kit (Aspartic Acid Substrate Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Creatinine (CRE) Assay Kit (Enzymatic Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
β2-Microglobulin (β2-MG) Assay Kit (Immunonephelometric Method) R1: 2×40 mL, R2: 1×20 mL
EUDAMED
IVD GeneralActive
Antistreptolysin “O”(ASO)Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Assay Kit (Peroxidase Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Alpha-Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Ferritin (FER) Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Total Cholesterol (CHO) Assay Kit (CHOD-PAP Method) R: 2×60 mL
EUDAMED
IVD GeneralActive
Total Protein (TP) Assay Kit (Biuret Method) R: 2×60 mL
EUDAMED
IVD GeneralActive
25-Hydroxyvitamin D (25-OH-VD) Assay Kit (Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Alanine aminotransferase (ALT) Assay Kit (Alanine Substrate Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Immunoglobulin M (IgM) Assay Kit (Immunonephelometric Method) Immunoglobulin M (IgM) Assay Kit (Immunonephelometric Method)
EUDAMED
IVD GeneralActive
Pepsinogen Ⅱ(PGⅡ)Assay Kit(Latex Immunoturbidimetric Method) R1: 2×54 mL, R2: 2×10 mL
EUDAMED
IVD GeneralActive
α-L-Fucosidase (AFU) Assay Kit (CNPF Substrate Method) R1: 2×60 mL
EUDAMED
IVD GeneralActive
Urea Assay Kit (Urease-GLDH Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Nonesterified Fatty Acid (NEFA)Assay Kit(ACS-ACOD Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
PepsinogenⅡ(PGⅡ)Assay Kit(Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Complement C4 Assay Kit (Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
5’-Nucleotidase (5'-NT) Assay Kit (Peroxidase Method) R1: 2×40 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Sialic Acid(SA)Assay Kit (Enzymatic Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Direct Bilirubin (DBIL) Assay Kit (Vanadate Oxidation Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Lipoprotein (a) [Lp(a)] Assay Kit ( Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Carcinoembryonic Antigen(CEA)Assay Kit(Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Automatic specific protein analyzer ST-280p
EUDAMED
Class AActive
Albumin (ALB) Assay Kit (Bromocresol Green Method) R: 2×60 mL
EUDAMED
IVD GeneralActive
Total Bilirubin (TBIL) Assay Kit (Vanadate Oxidation Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Glucose(GLU) Assay Kit (Hexokinase Method) R1: 2×50 mL, R2: 2×10 mL
EUDAMED
IVD GeneralActive
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody Assay Kit (Immunonephelometric Method) R1: 2×30 mL, R2: 1×20 mL
EUDAMED
IVD GeneralActive
Superoxide Dismutase(SOD) Assay Kit(Pyrogallol Method) R1: 2×45 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Lipoprotein-associated Phospholipase A2 (Lp-PLA2)Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Squamous Cell Carcinoma Antigen(SCC)Assay Kit (Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Kappa Light Chains (κ-LC) Assay Kit (Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Glycated Hemoglobin (HbA1c)Assay Kit (Latex Immunoturbidimetric Method) R1: 1×60 mL, R2: 1×20 mL, Hemolytic agent: 2×70 mL
EUDAMED
IVD GeneralActive
Kappa Light Chains (κ-LC) Assay Kit (Immunonephelometric Method) R1: 2×40 mL, R2: 1×20 mL
EUDAMED
IVD GeneralActive

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