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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: —
Email: [email protected]
Phone: —
PRRC Contact: bo Zhou
EUDAMED SRN: CN-MF-000043067
FDA FEI Number: —
DUNS Number: —

Catalogue (119)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Human Epididymis Protein 4（HE4）Assay Kit ( Chemiluminescent Immunoassay)	100 tests/kit	EUDAMED	IVD General	Active
High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Direct Method - Selective Inhibition Method)	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
Immunoglobulin M (IgM) Assay Kit（Immunoturbidimetric Method）	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
PepsinogenⅠ（PGⅠ）Assay Kit（Chemiluminescent Immunoassay）	100 tests/kit	EUDAMED	IVD General	Active
Creatine Kinase (CK) Assay Kit (Phosphocreatine Substrate Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Lambda Light Chains (λ-LC) Assay Kit (Immunonephelometric Method)	R1: 2×40 mL, R2: 1×20 mL	EUDAMED	IVD General	Active
Carbon Dioxide (CO2) Assay Kit (PEPC Enzymatic Method)	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
Glutathione Reductase (GR) Assay Kit (Glutathione Substrate Method)	R1: 2×50 mL, R2: 2×10 mL	EUDAMED	IVD General	Active
Immunoglobulin A (IgA) Assay kit (Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
Lactate Dehydrogenase (LDH) Assay Kit (Lactate Substrate Method)	R1: 2×50 mL, R2: 2×10 mL	EUDAMED	IVD General	Active
Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit (Latex Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
α1-Acid Glycoprotein（α1-AG）Assay Kit (Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
α-Amylase （α-AMY）Assay Kit (EPS Substrate Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Transferrin （TRF）Assay Kit（Immunoturbidimetric Method）	R1: 2×50 mL, R2: 2×10 mL	EUDAMED	IVD General	Active
β2-Microglobulin (β2-MG) Assay Kit (Latex Immunoturbidimetric Method)	R1: 1×16 mL, R2: 1×4 mL	EUDAMED	IVD General	Active
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody Assay Kit (Latex Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay)	100 tests/kit	EUDAMED	IVD General	Active
Albumin（ALB）Assay Kit （Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
α1-Microglobulin （α 1-MG） Assay Kit （Latex Immunoturbidimetric Method）	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Full-Range C-Reactive Protein (fCRP) Assay Kit (Immunonephelometric Method)	R1: 2×30 mL, R2: 1×12 mL, Sample diluent: 2×24 mL	EUDAMED	IVD General	Active
Transferrin (TRF) Assay Kit（Latex Immunoturbidimetric Method）	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Lipase (LPS) Assay Kit (Methylresorufin Method)	R1: 2×40 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
Triglyceride (TG) Assay Kit (GPO-PAP Method)	R: 2×60 mL	EUDAMED	IVD General	Active
Alkaline Phosphatase (ALP) Assay Kit (NPP Substrate-AMP Buffer Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
γ-Glutamyl Transferase (γ-GT) Assay Kit (GCANA Substrate Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Rheumatoid Factor (RF) Assay Kit (Immunonephelometric Method)	R1: 2×30 mL, R2: 1×15 mL	EUDAMED	IVD General	Active
Myeloperoxidase (MPO) Assay Kit (Latex Immunoturbidimetric Method)	R1: 2×45 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9（CA19-9）Assay Kit（Chemiluminescent Immunoassay）	100 tests/kit	EUDAMED	IVD General	Active
Cancer Antigen 125（CA125）Assay Kit（Chemiluminescent Immunoassay）	100 tests/kit	EUDAMED	IVD General	Active
Microalbuminuria (mALB)Assay Kit (Immunonephelometric Method)	R1: 2×40 mL, R2: 1×20 mL	EUDAMED	IVD General	Active
Immunoglobulin G (IgG) Assay Kit(Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
Immunoglobulin G (IgG) Assay Kit (Immunonephelometric Method)	R1: 2×30 mL, R2: 1×12.5 mL	EUDAMED	IVD General	Active
Serum Amyloid A Protein (SAA) Assay Kit (Immunonephelometric Method)	R1: 2×30 mL, R2: 1×12 mL, Sample diluent: 2×30 mL	EUDAMED	IVD General	Active
Adiponectin（ADP） Assay Kit (Latex Enhanced Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Creatine Kinase MB Isoenzyme (CK-MB) Assay Kit（Immunosuppression Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Glycated Albumin (GA)Assay Kit (Enzymatic Method)	942	EUDAMED	IVD General	Active
Myoglobin (MYO) Assay Kit (Immunoturbidimetric Method)	R1: 2×45 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Total Bile Acid （TBA）Assay Kit (Enzymatic Cycling Method)	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
N-acetyl-β-D-glucosaminidase (NAG) Assay Kit (MPT Substrate Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Cholinesterase (CHE) Assay Kit (Butyryl Thiocholine Substrate Method )	R1: 2×50 mL, R2: 2×10 mL	EUDAMED	IVD General	Active
Creatine Kinase MB Isoenzyme (CK-MB) Assay Kit (Latex Immunoturbidimetric Method)	R1: 2×45 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Lipoprotein-associated Phospholipase A2（Lp-PLA2） Assay Kit（Enzymatic Method）	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Immunonephelometric Method)	R1: 2×32 mL, R2: 1×16 mL	EUDAMED	IVD General	Active
Heparin Binding Protein (HBP) Assay Kit (Latex Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Neutrophil Gelatinase-associated Lipocalin (NGAL)Assay Kit(Latex lmmunoturbidimetric Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active
Antistreptolysin “O”(ASO) Assay Kit (Immunonephelometric Method)	R1: 2×30 mL, R2: 1×10 mL	EUDAMED	IVD General	Active
Urinary Immunoglobulin G (UIgG) Assay Kit (Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×20 mL	EUDAMED	IVD General	Active
Cystatin C (CysC) Assay Kit (Immunonephelometric Method)	R1: 2×30 mL, R2: 1×15 mL	EUDAMED	IVD General	Active
Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay)	100 tests/kit	EUDAMED	IVD General	Active
Microalbuminuria（mALB）Assay Kit ( Immunoturbidimetric Method)	R1: 2×60 mL, R2: 2×15 mL	EUDAMED	IVD General	Active

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