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Zybio Inc.

China·CN-MF-000003349

Last updated September 17, 2026

Information

Country
China
Address
No. 45 Shilin Avenue, Tiaodeng Town, Dadukou District, Chongqing, China
Website
zy-ivd.com
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Suifeng Deng
EUDAMED SRN
CN-MF-000003349
FDA FEI Number
3017098905
DUNS Number
—

Catalogue (176)

Page 3 of 4
DeviceModel / ReferenceRegistriesClassStatus
Immunoglobulin G (IgG) Kit(Immunoturbidimetric Method) 01.09.03.08.EC.01
EUDAMED
IVD GeneralActive
Wash Buffer 6012003
EUDAMED
Class AActive
Microbe Sample Pretreatment Kit 01.09.61.01.01.12
EUDAMED
Class AActive
Wash Buffer 6012002
EUDAMED
Class AActive
Cardiac Troponin I (cTnI) Kit (Latex Enhanced Immunoturbidimetric Method) 01.09.04.01.EC.01
EUDAMED
IVD GeneralActive
Mold Sample Pretreatment Kit 01.09.64.01.01.08
EUDAMED
Class AActive
Turbidity Calibrator 01.09.1F.01.16.02
EUDAMED
IVD GeneralActive
Hematology Analyzer 3030104
EUDAMED
Class BActive
Cleanser 01.09.1F.01.13.23
EUDAMED
Class AActive
Quantitative Real-time PCR System 02-17-01-0023-00
EUDAMED
Class AActive
Zybio Sample Probe Cleaning Solution
EUDAMED
Class AActive
Sialic Acid (SA) Kit (Enzymatic Method) 01.09.0A.01.EC.01
EUDAMED
IVD GeneralActive
Hematology Analyzer 02-13-04-0011-00
EUDAMED
Class BActive
Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method) 01.09.00.20.EC.01
EUDAMED
IVD GeneralActive
D-Dimer (D-D) Kit(Latex Enhanced Immunoturbidimetric Method) 01.09.08.02.EC.02
EUDAMED
IVD GeneralActive
Lactate Dehydrogenase (LDH) Kit (Rate Method) 01.09.04.06.EC.01
EUDAMED
IVD GeneralActive
Sheath Fluid 01.09.1F.01.11.12
EUDAMED
Class AActive
Urinalysis Strip (Dry Chemistry Method) 01.09.1F.01.01.06
EUDAMED
IVD GeneralActive
D-Dimer Assay (CLIA) 0602801
EUDAMED
IVD GeneralActive
Prealbumin (PA) Kit (Immunoturbidimetric Method) 01.09.00.15.EC.01
EUDAMED
IVD GeneralActive
Substrate 01.09.40.10.01.07
EUDAMED
Class AActive
Sediment Control 01.09.1F.01.08.06
EUDAMED
IVD GeneralActive
Immunoglobulin A (IgA) Kit(Immunoturbidimetric Method) 01.09.03.05.EC.01
EUDAMED
IVD GeneralActive
Sample Treatment Matrix Solution 01.09.63.01.01.15
EUDAMED
Class AActive
Color Control 01.09.1F.01.04.03
EUDAMED
IVD GeneralActive
CA 50 Assay (CLIA) 0603501
EUDAMED
IVD GeneralActive
Substrate 6012201
EUDAMED
Class AActive
Cystatin C (Cys C) Kit(Latex Enhanced Immunoturbidimetric Method) 01.09.01.03.EC.01
EUDAMED
IVD GeneralActive
Quantitative Real-time PCR System 02-17-01-0021-00
EUDAMED
Class AActive
High Sensitive C-Reactive Protein (hs-CRP) Kit (Immunoturbidimetric Method) 01.09.05.00.EC.01
EUDAMED
IVD GeneralActive
D-Dimer (D-D) Kit(Latex Enhanced Immunoturbidimetric Method) 01.09.08.02.EC.01
EUDAMED
IVD GeneralActive
Sample Treatment Matrix Solution 01.09.63.01.01.14
EUDAMED
Class AActive
Cell-free DNA Extraction Kit (Magnetic Bead Method) 0301806
EUDAMED
Class AActive
Rheumatoid Factor (RF) Kit(Latex Enhanced Immunoturbidimetric Method) 01.09.09.02.EC.01
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.08.T1.11
EUDAMED
Class AActive
CA 125 Assay (CLIA) 0602601
EUDAMED
IVD GeneralActive
CA 15-3 Assay (CLIA) 0601901
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.00.T1.09
EUDAMED
Class AActive
Check-P Control 01.09.31.01.Q.33
EUDAMED
Class CActive
Serum Amyloid A Protein Kit (Immunoassay) 01.09.30.01.01.05
EUDAMED
Class CActive
Creatine Kinase (CK) Kit (Rate Method) 01.09.04.03.EC.01
EUDAMED
IVD GeneralActive
AMH Assay (CLIA) 0603401
EUDAMED
IVD GeneralActive
Complement 1q (C1q) Kit (Immunoturbidimetric Method) 01.09.03.01.EC.01
EUDAMED
IVD GeneralActive
Complement 3 (C3) Kit(Immuno-transmission Turbidimetric Method) 01.09.03.02.EC.01
EUDAMED
IVD GeneralActive
Chemiluminescence Immunoassay Analyzer 02-12-02-0004-00
EUDAMED
Class AActive
Hematology Analyzer 02-13-01-0003-00
EUDAMED
IVD GeneralActive
Total Protein (TP) Kit (Biuret Method) 01.09.00.23.EC.01
EUDAMED
IVD GeneralActive
Nucleic Acid Isolation System 02-14-01-0014-00
EUDAMED
Class AActive
Wash Buffer 01.09.56.01.02.07
EUDAMED
Class AActive
Alanine Aminotransferase (ALT) Kit (Enzymatic Method) 01.09.00.05.EC.01
EUDAMED
IVD GeneralActive

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