BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    SpO2 probe M-50B 16-2358

    Reg #: 3018514222 · FEI: 3018514222 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LUXSHARE - ICT (NGHE AN ) LIMITED
    Registration Number
    3018514222
    FEI Number
    3018514222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.18, 03 STREET, VSIP NGHE AN INDUSTRIAL PARK, HUNG TAY COMMUNE, HUNG NGUYEN DISTRICT, NGHE AN PROVINCE, VIET
    City
    Nghe An
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K152563

    Owner / Operator

    Firm Name
    LUXSHARE - ICT (NGHE AN ) LIMITED
    Operator Number
    10093365
    Address
    NO.18, 03 STREET, VSIP NGHE AN INDUSTRIAL PARK, HUNG TAY COMMUNE, HUNG NGUYEN DISTRICT, NGHE AN PROVINCE, VIET
    City
    Nghe An
    State
    VN-22
    Postal Code
    880000
    Country
    VN
    Correspondent
    Luffy H Chen

    US Agent

    Business Name
    Austin Chen
    Contact Name
    Austin Chen
    Address
    480 N. McCarthy Blvd #280
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US
    Email
    [email protected]
    Phone
    408 9570535 ext. 59174

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    SpO2 probe M-50B 16-2358 Pulse Oximeter MD300M 16-835V2 SpO2 probe M-50C 16-2350 SpO2 probe M-50H 16-2356 SpO2 probe M-50E 16-2351 SpO2 probe M-50J037 16-2353 Pulse Oximeter MD300M 16-834V2 SpO2 probe M-50J035 16-2354 SpO2 probe M-50J033 16-2352 Pulse Oximeter MD300K2 900-8275 Pulse Oximeter MD300M-G HCSMD400

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)