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Guangzhou Hybribio Medicine Technology Ltd.

China·CN-MF-000027677

Last updated May 23, 2026

What Guangzhou Hybribio Medicine Technology Ltd. makes

The company develops in vitro diagnostic (IVD) kits for genetic and epigenetic testing, including real-time PCR and methylation analysis tools. These products detect gene polymorphisms and DNA methylation patterns linked to conditions such as hearing loss, pharmacogenetic responses, and metabolic disorders. Examples include kits for APOE and SLCO1B1 gene analysis, CYP enzyme polymorphism testing, and methylation assays for genes like SOX1-OT and HIST1H4F. Additional offerings include bisulfite conversion reagents for DNA methylation studies and HRM-based hearing loss susceptibility assays.

The portfolio comprises devices classified under Class A, IVD Annex II List B, and IVD General categories, reflecting their use in routine laboratory diagnostics and genetic screening. These products are registered in the EU’s eudamed database, ensuring compliance with European IVD regulations. The manufacturer is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
China
Address
No.71, Fenghuang 3rd Road, Guangzhou, China
Website
hybribio.cn
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Zicong Zheng
EUDAMED SRN
CN-MF-000027677
FDA FEI Number
—
DUNS Number
—

Catalogue (16)

DeviceModel / ReferenceRegistriesClassStatus
Hearing Loss Susceptibility GenoArray Diagnostic Kit HBGA-HLS
EUDAMED
IVD GeneralActive
Hearing Loss Susceptibility HRM Real-time PCR Kit HBRT-HLS
EUDAMED
IVD GeneralActive
APOE and SLCO1B1 Gene Polymorphism MCA Real-time PCR Kit HBRT-PGx/Statin
EUDAMED
IVD GeneralActive
Hearing Loss Susceptibility HRM Real-time PCR Kit HBRT-HLS
EUDAMED
IVD GeneralActive
CYP2C19 Gene Polymorphism MCA Real-Time PCR Kit HBRT-PGx/CPG
EUDAMED
IVD GeneralActive
CYP2C19 Gene Polymorphism MCA Real-Time PCR Kit HBRT-PGx/CPG
EUDAMED
IVD GeneralActive
DNAm Bisulfite Conversion Kit HBBC
EUDAMED
Class AActive
CYP2C9 and VKORC1 Gene Polymorphism MCA Real-Time PCR Kit HBRT-PGx/WFN
EUDAMED
IVD GeneralActive
CYP2C9 and VKORC1 Gene Polymorphism MCA Real-Time PCR Kit HBRT-PGx/WFN
EUDAMED
IVD GeneralActive
MTHFR Gene Polymorphism MCA Real-time PCR Kit HBRT-PGx/FA
EUDAMED
IVD GeneralActive
ALDH2 Gene Polymorphism MCA Real-Time PCR Kit HBRT-PGx/NTG
EUDAMED
IVD GeneralActive
SOX1-OT and HIST1H4F Methylation Real-time PCR Kit HBRT-BCDNAm
EUDAMED
IVD GeneralActive
Thalassemia GenoArray Diagnostic Kit HBGA-THAL
EUDAMED
IVD GeneralActive
SOX1-OT and HIST1H4F Methylation Real-time PCR Kit HBRT-BCDNAm
EUDAMED
IVD GeneralActive
SOX1 and PAX1 Methylation Real-time PCR Kit HBRT-CCDNAm
EUDAMED
IVD GeneralActive
STD3 Real-time PCR Kit HBRT-STD3: CT/NG/UU
EUDAMED
IVD Annex II List BActive

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