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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 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Apolipoprotein B (ApoB)Assay Kit (Immunoturbidimetric Method) R1: 2×50 mL, R2: 2×10 mL
EUDAMED
IVD GeneralActive
Uric Acid(UA)Assay Kit (Uricase Method) R: 2×60 mL
EUDAMED
IVD GeneralActive
Ischemia Modified Albumin (IMA)Assay Kit (Albumin Cobalt Binding Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Complement C3 Assay Kit (Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
Carbohydrate Antigen 50 (CA50) Assay Kit (Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
25-hydroxy Vitamin D (25-OH-VD) Assay Kit (Latex Enhanced Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Specific Proteins Multiconstituent Control 2×1 mL (2 levels)
EUDAMED
IVD GeneralActive
D-Dimer Assay Kit (Latex Immunoturbidimetric Method) R1: 2×45 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Cholyglycine (CG)Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×20 mL
EUDAMED
IVD GeneralActive
α2-Macroglobulin (α2-MG) Assay Kit (Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Rheumatoid Factor (RF)Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Specific Proteins Multiconstituent Calibrator 6×1 mL (6 levels)
EUDAMED
IVD GeneralActive
Fibrin/Fibrinogen Degradation Products(FDP)Assay Kit(Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Cystatin C (CysC)Assay Kit (Latex Immunoturbidimetric Method) R1: 2×54 mL, R2: 2×18 mL
EUDAMED
IVD GeneralActive
Apolipoprotein A1 (ApoA1) Assay Kit (Immunoturbidimetric Method) R1: 2×50 mL, R2: 2×10 mL
EUDAMED
IVD GeneralActive
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Assay Kit (α-Ketobutyrate Substrate Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive
Homocysteine (HCY)Assay Kit (Enzymatic Cycling Method) R1: 2×60 mL, R2: 2×15 mL, Calibrator: 2×0.5 mL (2 levels, optional), Control: 2×0.5 mL (2 levels, optional)
EUDAMED
IVD GeneralActive
Cytokeratin 19 Fragment (CYFRA21-1) Assay Kit (Chemiluminescent Immunoassay) 100 tests/kit
EUDAMED
IVD GeneralActive
Cardiac Troponin I (cTnI) Assay Kit (Latex Immunoturbidimetric Method) R1: 2×60 mL, R2: 2×15 mL
EUDAMED
IVD GeneralActive

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