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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 (175)

Page 1 of 4
DeviceModel / ReferenceRegistriesClassStatus
Chemistry Analyzer 02-10-02-0003-00
EUDAMED
Class AActive
Chemistry analyzer 02-10-00-0013-00
EUDAMED
Class AActive
SCCA Assay (CLIA) 0603701
EUDAMED
IVD GeneralActive
Microbe Sample Pretreatment Kit 01.09.61.01.01.11
EUDAMED
Class AActive
CA 242 Assay (CLIA) 0603601
EUDAMED
IVD GeneralActive
Magnesium (Mg) Kit (Xylidyl Blue Method) 01.09.0C.02.EC.01
EUDAMED
IVD GeneralActive
Microbe Sample Pretreatment Kit 01.09.61.01.01.13
EUDAMED
Class AActive
α-Hydroxybutyric Acid Dehydrogenase (α-HBDH) Kit (Rate Method) 01.09.04.00.EC.01
EUDAMED
IVD GeneralActive
Probe Detergent 042304004
EUDAMED
Class AActive
Microalbuminuria (mALB) Kit(Immunoturbidimetric Method) 01.09.01.08.EC.01
EUDAMED
IVD GeneralActive
BNP Assay (CLIA) 01.09.41.05.01.02
EUDAMED
IVD GeneralActive
Check-P Control 01.09.31.01.Q.35
EUDAMED
Class CActive
Calcium (Ca) Kit (Arsenazo III Method) 01.09.0C.01.EC.01
EUDAMED
IVD GeneralActive
C-Reactive Protein Kit (Immunoturbidimetric Method) 01.09.30.00.Z.48
EUDAMED
Class CActive
Glutathione Reductase (GR) Kit (Rate Method) 01.09.00.12.EC.01
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.08.T1.10
EUDAMED
Class AActive
ProGRP Assay (CLIA) 0602501
EUDAMED
IVD GeneralActive
PG Ⅰ Assay (CLIA) 0602901
EUDAMED
IVD GeneralActive
Non-Esterified Fatty Acid (NEFA) Kit (Enzymatic Method) 01.09.02.05.EC.01
EUDAMED
IVD GeneralActive
Ferritin Assay (CLIA) 0602101
EUDAMED
IVD GeneralActive
HE4 Assay (CLIA) 0603801
EUDAMED
IVD GeneralActive
Quantitative Real-time PCR System 02-17-01-0012-00
EUDAMED
Class AActive
Aspartate Aminotransferase (AST) Kit (Enzymatic Method) 01.09.00.16.EC.01
EUDAMED
IVD GeneralActive
Apolipoprotein A1 (Apo A1) Kit (Immunoturbidimetric Method) 01.09.02.06.EC.01
EUDAMED
IVD GeneralActive
UDC-Control 01.09.1F.01.03.04
EUDAMED
IVD GeneralActive
SG Control 01.09.1F.01.05.03
EUDAMED
IVD GeneralActive
Total Cholesterol (CHOL) Kit (Enzymatic Method) 01.09.02.10.EC.01
EUDAMED
IVD GeneralActive
SG Calibrator 01.09.1F.01.15.02
EUDAMED
IVD GeneralActive
TG Assay (CLIA) 0602401
EUDAMED
IVD GeneralActive
Lyse 01.09.31.05.Z5.07
EUDAMED
Class AActive
Low Density Lipoprotein Cholesterol (LDL-C) Kit (Enzymatic Method) 01.09.02.00.EC.01
EUDAMED
IVD GeneralActive
Apolipoprotein B (Apo B) Kit(Immunoturbidimetric Method) 01.09.02.07.EC.01
EUDAMED
IVD GeneralActive
CA 19-9 Assay (CLIA) 0601701
EUDAMED
IVD GeneralActive
Wash Solution 01.09.1F.01.13.11
EUDAMED
Class AActive
Glycated Hemoglobin A1c (HbA1c) Kit (Immunoturbidimetric Method) 01.09.06.03.EC.01
EUDAMED
IVD GeneralActive
C-Peptide Assay (CLIA) 0603301
EUDAMED
IVD GeneralActive
IL-6 Assay (CLIA) 2 × 50 Tests/Kit
EUDAMED
IVD GeneralActive
α-Amylase (α-AMY) Kit (E-pNP-G7 Method) 01.09.0B.00.EC.01
EUDAMED
IVD GeneralActive
C-Reactive Protein Kit (Immunoturbidimetric Method) 3011001
EUDAMED
Class CActive
Hematology Analyzer 02-13-04-0010-00
EUDAMED
Class BActive
AFP Assay (CLIA) 0601501
EUDAMED
IVD GeneralActive
Substrate 01.09.40.10.01.06
EUDAMED
Class AActive
Insulin Assay (CLIA) 0603201
EUDAMED
IVD GeneralActive
C-Reactive Protein Kit (Immunoturbidimetric Method) 01.09.30.00.Z.52
EUDAMED
Class CActive
Vitamin B12 Assay (CLIA) 01.09.4E.01.01.02
EUDAMED
IVD GeneralActive
25-OH-Vitamin D Assay (CLIA) 01.09.4F. 01.01.02
EUDAMED
IVD GeneralActive
Blood Culture Positive Sample Pretreatment Kit 01.09.62.01.01.10
EUDAMED
Class AActive
Ultra Fast Real-time PCR System 02-17-01-0006-00
EUDAMED
Class AActive
Urinalysis Diluent 01.09.1F.01.12.05
EUDAMED
Class AActive
Fluorescence Immunochromatography Analyzer 02-11-03-0001-00
EUDAMED
Class AActive

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