BEUDAMED
    FDA Registration Active 🇨🇳 China

    ONECHIPDX BIOTECH (SUZHOU) CO., LTD

    Reg #: 3038625004 · FEI: 3038625004 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    ONECHIPDX BIOTECH (SUZHOU) CO., LTD
    Registration Number
    3038625004
    FEI Number
    3038625004
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 302, A6 Bldg, Phase I Biomedical Industrial Park, No.218 Xinghu Str, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240402

    Owner / Operator

    Firm Name
    CytoChip Inc.
    Operator Number
    10093532
    Address
    18 Technology Dr, Suite 200
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Wendian Shi

    US Agent

    Business Name
    CytoChip Inc.
    Contact Name
    Wendian Shi
    Address
    18 Technology Dr Ste 200
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 5226668

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ
    Control, Cell Counter, Normal And Abnormal JCN

    Proprietary Names

    CitoCBC System CitoCBC Control

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device