BEUDAMED
    FDA Registration Active 🇨🇳 China

    TSH Elecsys cobas e 200 V2

    Reg #: 3020917535 · FEI: 3020917535 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Roche Diagnostics (Suzhou) Ltd.
    Registration Number
    3020917535
    FEI Number
    3020917535
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.259 Zhongyuan Road
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K190773

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW

    Proprietary Names

    TSH Elecsys cobas e 200 V2 Elecsys TSH TSH Elecsys E2G 300 V2

    Establishment Types

    Manufacture Medical Device