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Zhejiang Orient Gene Biotech Co., Ltd

China·CN-MF-000017965

Last updated June 8, 2026

Information

Country
China
Address
3787#, East Yangguang Avenue, Dipu Street, Anji 313300, Huzhou,Zhejiang, China
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Joyce Pang
EUDAMED SRN
CN-MF-000017965
FDA FEI Number
—
DUNS Number
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Catalogue (435)

Page 3 of 9
DeviceModel / ReferenceRegistriesClassStatus
iGFBP-1 Rapid Test Strip (Cervical Secretion) GAIGF1-501a
EUDAMED
IVD GeneralActive
Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) N7001A
EUDAMED
IVD GeneralActive
IgE Quantitative Test Kit(Time-Resolved FIA) FGIGE-302a
EUDAMED
IVD GeneralActive
IL-6 Control FDIL6-PN20
EUDAMED
IVD GeneralActive
One Step Multi-Drug Screen Test Dip Card (Urine) GBDOA-1X4
EUDAMED
IVD GeneralActive
Strep A Antigen Control Kit GCSTR-PN2
EUDAMED
IVD GeneralActive
Group A Streptococcus Detection Kit (Fluorescence PCR) AGAS01-AOG48E; AGAS01D-AOG48E
EUDAMED
IVD GeneralActive
Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method) 2RET9A11
EUDAMED
IVD GeneralActive
PCT Quantitative Test Kit (Time-Resolved FIA) FDPCT-402a
EUDAMED
IVD GeneralActive
In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay) 1CKMBB12
EUDAMED
IVD GeneralActive
Vitamin B12 Quantitative Test Kit (Time-Resolved FIA) FIVB12-302a
EUDAMED
IVD GeneralActive
T3 Control FKTT3-PN20
EUDAMED
IVD GeneralActive
Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method) 1TM3B11
EUDAMED
IVD GeneralActive
Saliva Alcohol Test Strip DAL-701a
EUDAMED
IVD GeneralActive
25-OH-VD Control FIVD-PN20
EUDAMED
IVD GeneralActive
AMH Quantitative Test Kit (Time-Resolved FIA) FAAMH-402a
EUDAMED
IVD GeneralActive
FERR Control FEFER-PN20
EUDAMED
IVD GeneralActive
Oral Fluid Drug Test Cylinder GBDSA-XXXXJX
EUDAMED
IVD GeneralActive
Influenza A/B Detection Kit (Direct Fluorescence PCR) AFAB01-AOG48E; AFAB01-AOG96E
EUDAMED
IVD GeneralActive
SAA QuantitativeTest Kit (Time-Resolved FIA) FDSAA-402a
EUDAMED
IVD GeneralActive
RSV Antigen Fluorescent Rapid Test Cassette (Swab) FCRSV-502a
EUDAMED
IVD GeneralActive
Adenovirus Antigen FIA Control Kit FCADE-PN2
EUDAMED
IVD GeneralActive
Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E
EUDAMED
IVD GeneralActive
One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma) GCCHK-402a
EUDAMED
IVD GeneralActive
Hair Drug Rapid Test Kit (Time-Resolved FIA) FBXXX-1102/FBDOA-11X5
EUDAMED
IVD GeneralActive
Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method) 2RYT8A11
EUDAMED
IVD GeneralActive
Urinalysis Strips URS-11T
EUDAMED
IVD GeneralActive
Human Papillomavirus 18 Types Detection Kit (Fluorescence PCR) AHPV1801-AOG48E
EUDAMED
IVD GeneralActive
AFP Quantitative Test Kit (Time-Resolved FIA) FEAFP-302a
EUDAMED
IVD GeneralActive
One Step Ovulation Test Strip (Urine) GALH-101a
EUDAMED
IVD GeneralActive
Cortisol Quantitative Test Kit (Time-Resolved FIA) FKCOR-302a
EUDAMED
IVD GeneralActive
IL-6 Quantitative Test Kit (Time-Resolved FIA) FDIL6-402a
EUDAMED
IVD GeneralActive
PCT/IL-6 Control FDPI-PN20
EUDAMED
IVD GeneralActive
Monkeypox Ag Rapid Test Cassette (Swab) GCMKP-502b
EUDAMED
IVD GeneralActive
One Step Fentanyl Test Strip (Urine) GBFEN-101b
EUDAMED
IVD GeneralActive
Epstein-Barr virus Detection Kit (Fluorescence PCR) "AEBV01-AOG48E, AEBV01D-AOG48E"
EUDAMED
IVD GeneralActive
One Step Ovulation Test Cassette (Urine) GALH-102b
EUDAMED
IVD GeneralActive
TSH Control FITSH-PN20
EUDAMED
IVD GeneralActive
Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) FCADE-502a
EUDAMED
IVD GeneralActive
CRP Control FDWCR-PN20
EUDAMED
IVD GeneralActive
HbA1c Control FIHBA-PN20
EUDAMED
IVD GeneralActive
D-Dimer/cTnI/NT-proBNP Quantitative Test Kit (Time-Resolved FIA) FDDTB-425a
EUDAMED
IVD GeneralActive
One Step Lysergic Acid Diethylamide Test Strip (Urine) GBLSD-101a
EUDAMED
IVD GeneralActive
Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) GDTRO-402d
EUDAMED
IVD GeneralActive
M. pneumoniae Ag Rapid Test Cassette (Swab) GCMP-502a
EUDAMED
IVD GeneralActive
VB12 Control FIVB12-LP3
EUDAMED
IVD GeneralActive
NGAL Quantitative Test Kit (Time-Resolved FIA) FINGA-402a
EUDAMED
IVD GeneralActive
Adenovirus Antigen Control Kit GCADE-PN2
EUDAMED
IVD GeneralActive
LH Control FALH-PN20
EUDAMED
IVD GeneralActive
Beta2-MG Control FIMG-PN20
EUDAMED
IVD GeneralActive

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