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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
—

Catalogue (465)

Page 9 of 10
DeviceModel / ReferenceRegistriesClassStatus
Transferrin Rapid Test Device (Feces) GETF-606a
EUDAMED
IVD GeneralActive
One Step Pregnancy Test Cassette (Urine) GAHCG-102a
EUDAMED
IVD GeneralActive
Clinical Emergency Lyophilized Kit 15 EC-001
EUDAMED
IVD GeneralActive
Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-425a
EUDAMED
IVD GeneralActive
Fecal Occult Blood Rapid Test Device (Feces) GEFOB-606b
EUDAMED
IVD GeneralActive
HCG Pregnancy Rapid Test GAHCG-102a-2T
EUDAMED
IVD devices for self-testingActive
Toxoplasma gondii (Toxo) IgG/IgM Rapid Test GCTOX(IgG/IgM)-302a
EUDAMED
IVD Annex II List BActive
HCG Pregnancy Rapid Test GAHCG-102b-25T
EUDAMED
IVD devices for self-testingActive
One Step Multi-Drug Test Dip Card (Urine) GBDOA-134-019
EUDAMED
Class BActive
HCG Pregnancy Rapid Test GAHCG-103d-1T
EUDAMED
IVD devices for self-testingActive
Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) GCFCRA-545a
EUDAMED
IVD GeneralActive
Rapid Flu A&B+RSV+Adeno Antigen Test GCFRA-T525a-DRH5
EUDAMED
Class CActive
Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCSYP-402a
EUDAMED
IVD GeneralActive
Adenovirus Rapid Test Cassette (Feces) GCADE-602a
EUDAMED
IVD GeneralActive
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) GCFC-T502a-H20
EUDAMED
Class CActive
Healgen-800 Urine Analyzer Healgen 800
EUDAMED
Class AActive
Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) GDTRO-402b
EUDAMED
IVD GeneralActive
Human Ferritin Rapid Test Cassette (Whole blood/Serum/Plasma) GEFER-402a
EUDAMED
IVD GeneralActive
Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) GDMYO-402a
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction Reagent (Magnetic beads) N3002D
EUDAMED
Class AActive
Premom Pregnancy Test PMS-150
EUDAMED
IVD devices for self-testingActive
Rheumatoid Factor IgM Rapid Test Cassette (Serum/Plasma) GGRF(IgM)-302a
EUDAMED
IVD GeneralActive
One Step Microalbumin Test Cassette (Urine) GIHSA-102a
EUDAMED
IVD GeneralActive
One Step Multi-Drug Test Dip Card (Urine) GBDOA-1124-009
EUDAMED
Class BActive
Adenovirus Antigen Rapid Test Cassette (Swab) GCADE-502Ca
EUDAMED
IVD GeneralActive
One Step Multi-Drug Test Dip Card (Urine) GBDOA-1104-030
EUDAMED
Class BActive
Urinalysis Strips URS-2T
EUDAMED
IVD GeneralActive
HCG Pregnancy Rapid Test GAHCG-103d-5T
EUDAMED
IVD devices for self-testingActive
Digital Pregnancy Test GAHCG-D103a-1T
EUDAMED
IVD devices for self-testingActive
Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) GECEA-402a
EUDAMED
IVD GeneralActive
COVID-19 IgG/IgM CONTROL Kit GCCOV-PN10,GCCOV-PN20
EUDAMED
IVD GeneralActive
Fecal Occult Blood Rapid Test Cassette (Feces) GEFOB-602Cb
EUDAMED
IVD GeneralActive
Fecal Occult Blood Control Kit GEFOB-PN2
EUDAMED
IVD GeneralActive
One Step Pregnancy Test Strip (Urine) GAHCG-101a
EUDAMED
IVD GeneralActive
One Step Menopause Test Cassette (Urine) GAFSH-102a
EUDAMED
IVD GeneralActive
Immunofluorescence Analyzer OG-H180
EUDAMED
Class AActive
H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) GCHP-401a
EUDAMED
IVD GeneralActive
D-Dimer Rapid Test Cassette (Whole Blood/Plasma) GDDDI-402b
EUDAMED
IVD GeneralActive
FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces) GEFTHRA-T636a
EUDAMED
IVD GeneralActive
Renal Function Glucose and Lipid Lyophilized Kit 10 KF-002
EUDAMED
IVD GeneralActive
Easy @ Home Pregnancy Test EZW1-MN-5
EUDAMED
IVD devices for self-testingActive
Urine Analyzer Healgen 500
EUDAMED
Class AActive
Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) GCCD(GDH)-602a
EUDAMED
IVD GeneralActive
Mini Immunofluorescence Analyzer OG-H100
EUDAMED
Class AActive
Rapid COVID-19 (Antigen) Self-Test GCCOV-502a-H5OGE
EUDAMED
IVD devices for self-testingActive
One Step Pregnancy Test Cassette (Urine) GAHCG-102b
EUDAMED
IVD GeneralActive
Myocardial Enzyme and Lipid Lyophilized Kit 10 CAR-001
EUDAMED
IVD GeneralActive
Transferrin Rapid Test Strip (Feces) GETF-601a
EUDAMED
IVD GeneralActive
Influenza A & B Ag Rapid Test Strip (Swab) GCFLU(A/B)-501a
EUDAMED
IVD GeneralActive
Prostate Specific Antigen (PSA) Rapid Test Strip (Whole blood/Serum/Plasma) GEPSA-401a
EUDAMED
IVD Annex II List BActive

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