BEUDAMED
    FDA Registration Active 🇨🇳 China

    Luna G3 BPAP System

    Reg #: 3008566132 · FEI: 3008566132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BMC MEDICAL CO., LTD.
    Registration Number
    3008566132
    FEI Number
    3008566132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road
    City
    Fengtai District Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212263

    Owner / Operator

    Firm Name
    BMC Medical Co., Ltd
    Operator Number
    10040296
    Address
    Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road
    City
    Fengtai District
    State
    Beijing
    Postal Code
    100073
    Country
    CN
    Correspondent
    Fang Zheng

    US Agent

    Business Name
    Mid-Link International, Inc.
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Luna G3 BPAP System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device