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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 5 of 10
DeviceModel / ReferenceRegistriesClassStatus
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
G-17 Quantitative Test Kit (Time-Resolved FIA) FEG17-302a-G16
EUDAMED
IVD GeneralActive
Rotavirus and Adenovirus Antigen Control Kit GCROA/ADE-PN2
EUDAMED
IVD GeneralActive
One Step Phencyclidine Test Strip (Urine) GBPCP-101a
EUDAMED
IVD GeneralActive
Chikungunya IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCCHK(IgG/IgM)-402b
EUDAMED
IVD GeneralActive
Free T4 Quantitative Test Kit (Time-Resolved FIA) FKFT4-302a
EUDAMED
IVD GeneralActive
One Step Hydrocodone Test Strip (Urine) GBHCD-101a
EUDAMED
IVD GeneralActive
One Step Phencyclidine Test Cassette (Urine) GBPCP-102a
EUDAMED
IVD GeneralActive
RSV Antigen Control Kit GCRSV-PN2,GCRSV-PN10
EUDAMED
IVD GeneralActive
One Step Methaqualone Test Cassette (Urine) GBMQL-102a
EUDAMED
IVD GeneralActive
Trichomonas Ag Rapid Test Cassette (Swab) GCTV-502a
EUDAMED
IVD GeneralActive
Urinalysis Strips URS-12T
EUDAMED
IVD GeneralActive
One Step Buprenorphine Test Strip (Urine) GBBUP-101a
EUDAMED
IVD GeneralActive
One Step 3, 4-Methylenedioxypyrovalerone Test Cassette (Urine) GBMDP-102a
EUDAMED
IVD GeneralActive
One Step Drugs of Abuse Test Strip (Urine) GBXXX-101
EUDAMED
IVD GeneralActive
Oral Fluid Drug Test Mini Cube GBDSA-XXXXLX
EUDAMED
IVD GeneralActive
COVID-19 & Influenza A/B Rapid Test Cassette (Swab) GCFC-525Sa
EUDAMED
IVD GeneralActive
Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method) 1GF3B11
EUDAMED
IVD GeneralActive
OG-N32 Nucleic Acid Purification System MNAP01-AOGE
EUDAMED
IVD GeneralActive
One Step Fentanyl Test Cassette (Urine) GBFEN-102b
EUDAMED
IVD GeneralActive
Urinalysis Strips URS-14T
EUDAMED
IVD GeneralActive
MAU Quantitative Test Kit (Time-Resolved FIA) FIHSA-102a
EUDAMED
IVD GeneralActive
PROG Control FAPRO-PN20
EUDAMED
IVD GeneralActive
Urinalysis Strips URS-10T
EUDAMED
IVD GeneralActive
One Step K2 Test Cassette (Urine) GBK2-102a
EUDAMED
IVD GeneralActive
One Step UR-144 Test Cassette (Urine) GBUR-102a
EUDAMED
IVD GeneralActive
Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method) 1TM2B11
EUDAMED
IVD GeneralActive
T3 Quantitative Test Kit (Time-Resolved FIA) FKTT3-402a
EUDAMED
IVD GeneralActive
One Step Buprenorphine Test Cassette (Urine) GBBUP-102a
EUDAMED
IVD GeneralActive
Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a
EUDAMED
IVD GeneralActive
One Step Ethyl Glucuronide Test Cassette (Urine) GBETG-102b
EUDAMED
IVD GeneralActive
Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCLEP(IgG/IgM)-402a
EUDAMED
IVD GeneralActive
Cortisol Quantitative Test Kit (Time-Resolved FIA) FKCOR-402a
EUDAMED
IVD GeneralActive
One Step Tricyclic Antidepressants Test Cassette (Urine) GBTCA-102a
EUDAMED
IVD GeneralActive
Urinalysis Strips URS-9T
EUDAMED
IVD GeneralActive
Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method) 1TM7B11
EUDAMED
IVD GeneralActive
CRP/SAA Control FDCS-PN20
EUDAMED
IVD GeneralActive

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