BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI ZJ BIO-TECH CO., LTD.

    Reg #: 3007143373 · FEI: 3007143373 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    21
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    SHANGHAI ZJ BIO-TECH CO., LTD.
    Registration Number
    3007143373
    FEI Number
    3007143373
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    26 Building, 588 XINJUNHUAN ROAD, Pujiang High-tech Park.
    City
    SHANGHAI
    Country
    CN

    Owner / Operator

    Firm Name
    Shanghai ZJ Bio-Tech Co., Ltd.
    Operator Number
    10048869
    Address
    588 XINJUNHUAN ROAD, BUILDING 26
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201114
    Country
    CN
    Correspondent
    Huihui Yang

    US Agent

    Business Name
    LIFERIVER BIO-TECH (UNITED STATES) CORP.
    Contact Name
    WALTER ZHANG
    Address
    505 Coast Blvd. South, Suite 401 La Jolla, CALIFORNIA, 92037, UNITED STATES
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 3526520

    Products

    Device Name Product Code
    Instrumentation For Clinical Multiplex Test Systems NSU
    Reagents, Specific, Analyte MVU
    Clinical Sample Concentrator JJH

    Proprietary Names

    Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini 4800 Plus) Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini3200) Automated Workstation for Nucleic Acid Extraction & PCR Setup (Autra4800 Plus) Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800) Liferiver Intelligent Molecular Mobile Mini-Lab Life9600 Real-Time PCR System Automated Workstation for Nucleic Acid Extraction & PCR Setup (Autra9600 Plus) Viral RNA Isolation Kit (Preloaded for Auto-Extraction) Liferiver@ AutoEX36 A Extraction Kit Viral RNA Extraction Kit (for Auto-Extraction) Viral RNA Isolation Kit (for Auto-Extraction) Automated Nucleic Acid Extraction Instrument (EX3600) Automated Nucleic Acid Extraction Instrument (EX9600) Specimen Pretreatment system (QGMate) Automated Nucleic Acid Extraction Instrument (EX9600 Plus) Automated Nucleic Acid Extraction Instrument (Autra9600) Specimen Distribution System (AutraMate Plus) Specimen Distribution System (AutraMate Super) Automated Nucleic Acid Extraction Instrument (EX3600 Plus) Automated Workstation for Sample Preparation (Autra9600 Super) Automated Nucleic Acid Extraction Instrument (EX1600 Plus)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor