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Hangzhou Dalton BioSciences, Ltd.

China·CN-MF-000036196

Last updated September 18, 2026

What Hangzhou Dalton BioSciences, Ltd. makes

Hangzhou Dalton BioSciences, Ltd. manufactures diagnostic devices for HPV testing, including a high-risk HPV genotyping system and nucleic acid detection kits (Hybrid Capture-CLIA). Their portfolio also includes laboratory instruments like chemiluminescence immunoassay analyzers, automatic immunocytochemical staining machines, and liquid-based cytology slide processors, alongside consumables such as wash buffers, specimen preservation solutions, antigen retrieval buffers, and cell preservation solutions. These products are designed for in vitro diagnostic use in clinical and research settings.

The company’s devices are classified under Class A, Class C, and In Vitro Diagnostic (IVD) General categories, with some products listed in the EU’s eudamed registry. The manufacturer is based in China and adheres to relevant regulatory frameworks for diagnostic medical devices in their markets of operation.

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

Information

Country
China
Address
2nd & 3rd Floor of Building 3, 1 Weiye Road, Hangzhou, Zhejiang, Hangzhou, Zhejiang, China
LinkedIn
—
Facebook
—
Phone
+86-15397083692
PRRC Contact
Yingjia Shou
EUDAMED SRN
CN-MF-000036196
FDA FEI Number
—
DUNS Number
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Catalogue (12)

DeviceModel / ReferenceRegistriesClassStatus
High Risk Human Papillomavirus (HPV) Genotyping System HPVS02
EUDAMED
IVD GeneralActive
Chemiluminescence Immunoassay Analyzer CS-SA301C
EUDAMED
Class AActive
Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA) DH3-096
EUDAMED
Class CActive
Automatic immunocytochemical staining machine HB-100H
EUDAMED
Class AActive
Wash Buffer WB3-150
EUDAMED
Class AActive
Specimen Preservation Solution SPS-045
EUDAMED
Class CActive
Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA) DH3-192
EUDAMED
Class CActive
Antigen Retrieval Buffer AR3-5000
EUDAMED
Class AActive
Automatic Hybrid Capture System HB-304C
EUDAMED
Class AActive
Antigen Retrieval Buffer AR3-100
EUDAMED
Class AActive
Cell Preservation Solution CPS-025-20
EUDAMED
Class AActive
Liquid-Based Cytology Slide Processor ZP-2A
EUDAMED
Class AActive

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