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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 (465)

Page 4 of 10
DeviceModel / ReferenceRegistriesClassStatus
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
fT3 Control FKFT3-PN20
EUDAMED
IVD GeneralActive
One Step Ovulation Test Cassette (Urine) GALH-102a
EUDAMED
IVD GeneralActive
In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) 1CTNTB12
EUDAMED
IVD GeneralActive
One Step Methylphenidate Test Cassette (Urine) GBMPD-102a
EUDAMED
IVD GeneralActive
V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces) GCVCH(O1/O9)-602a
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis Complex Detection Kit (Fluorescence PCR) AMTBC01-AOG48E; AMTBC01-AOG96E;AMTBC01D-AOG48E; AMTBC01D-AOG96E;
EUDAMED
IVD GeneralActive
Ferritin Quantitative Test Kit (Time-Resolved FIA) FEFER-402a
EUDAMED
IVD GeneralActive
PCT/CRP Control FDPC-LP3
EUDAMED
IVD GeneralActive
Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method) 1TM6B11
EUDAMED
IVD GeneralActive
Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMKP-402a
EUDAMED
IVD GeneralActive
FSH Quantitative Test Kit (Time-Resolved FIA) FAFSH-402a
EUDAMED
IVD GeneralActive
cTnT Control FDTNT-PN20
EUDAMED
IVD GeneralActive
One Step Ketamine Test Strip (Urine) GBKET-101a
EUDAMED
IVD GeneralActive
Vaginal pH Rapid Test Strip (Swab) VPH-501a
EUDAMED
IVD GeneralActive
Vaginal pH Rapid Test Strip (Swab) VPH-501a
EUDAMED
IVD GeneralActive
One Step Ethyl Glucuronide Test Strip (Urine) GBETG-101b
EUDAMED
IVD GeneralActive
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) FDCAR-T402a
EUDAMED
IVD GeneralActive
Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCTB-402a
EUDAMED
IVD GeneralActive
Norovirus Antigen Rapid Test Cassette (Feces) GCNOR-602a
EUDAMED
IVD GeneralActive
One Step Opiate Test Cassette (Urine) GBOPI-102a
EUDAMED
IVD GeneralActive
PCT/CRP Quantitative Test Kit (Time-Resolved FIA) FDPC-T402a-G16
EUDAMED
IVD GeneralActive
Urinary Tract Infection Test Strip UTI-2T
EUDAMED
IVD GeneralActive
AMH Quantitative Test Kit (Time-Resolved FIA) FAAMH-302a
EUDAMED
IVD GeneralActive
One Step Tricyclic Antidepressants Test Strip (Urine) GBTCA-101a
EUDAMED
IVD GeneralActive
NT-proBNP Control FDBNP-PN20
EUDAMED
IVD GeneralActive
Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method) 1AA15B11
EUDAMED
IVD GeneralActive
Drugs of Abuse Rapid Test Cassette(Hair) GBDOA-11X5
EUDAMED
IVD GeneralActive
One Step Oxycodone Test Strip (Urine) GBOXY-101a
EUDAMED
IVD GeneralActive
One Step Multi-Drug Screen Test Vacuum Cup (Urine) GBDOAVC-1X6
EUDAMED
IVD GeneralActive
NT-proBNP Quantitative Test Kit (Time-Resolved FIA) FDBNP-402a
EUDAMED
IVD GeneralActive
Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method) 2HPV29A11
EUDAMED
IVD GeneralActive
MTBC Controls AMTBZK01-AHG2E
EUDAMED
IVD GeneralActive
M. pneumonia IgM Rapid Test Cassette (Serum/Plasma) GCMP(IgM)-302a
EUDAMED
IVD GeneralActive
cTnI Quantitative Test Kit (Time-Resolved FIA) FDTRO-402b
EUDAMED
IVD GeneralActive
Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a
EUDAMED
IVD GeneralActive
One Step Hydrocodone Test Cassette (Urine) GBHCD-102a
EUDAMED
IVD GeneralActive
One Step UR-144 Test Strip (Urine) GBUR-101a
EUDAMED
IVD GeneralActive

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