BEUDAMED
    FDA Registration Active 🇨🇳 China

    Pure Comfort Safety Lancets

    Reg #: 3006899020 · FEI: 3006899020 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HUAIAN HENING MEDICAL INSTRUMENTS CO ., LTD and its Subsidiary HUAIAN JUNRAN IMP.&EXP. TRADING CO.,LTD
    Registration Number
    3006899020
    FEI Number
    3006899020
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.6 West Hongdou Road Economic Development Zone
    City
    Huaian Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223313

    Owner / Operator

    Firm Name
    HOME AIDE DIAGNOSTICS, INC.
    Operator Number
    9087599
    Address
    1072 S. Powerline Rd., --
    City
    Deerfield Bch
    State
    FL
    Postal Code
    33442
    Country
    US
    Correspondent
    AMGAD - GIRGIS

    Products

    Device Name Product Code
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    Pure Comfort Safety Lancets

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device