BEUDAMED
    FDA Registration Active 🇨🇳 China

    SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.

    Reg #: 3004468256 · FEI: 3004468256 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    4

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    Registration Details

    Registration Name
    SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.
    Registration Number
    3004468256
    FEI Number
    3004468256
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Beiqiao Town
    City
    Suzhou City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221778

    Owner / Operator

    Firm Name
    Suzhou KYUAN Medical Apparatus Co., Ltd.
    Operator Number
    10077840
    Address
    Beiqiao Town
    City
    Suzhou City
    State
    Jiangsu
    Postal Code
    215144
    Country
    CN
    Correspondent
    Shi Ye

    US Agent

    Business Name
    MediPurpose Inc
    Contact Name
    Adeline Yi
    Address
    3883 Rogers Bridge Rd. NW, Ste 501
    City
    Duluth
    State
    GA
    ZIP
    30097
    Country
    US
    Email
    [email protected]
    Phone
    404 8553655

    Products

    Device Name Product Code
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Blade, Scalpel GES
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK

    Proprietary Names

    Disposable Safety Lancets Disposable Blood Lancets

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device