BEUDAMED
    FDA Registration Active 🇨🇳 China

    LT-300 HD

    Reg #: 3017221021 · FEI: 3017221021 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIGOWILL BIO MEDITECH LIMITED
    Registration Number
    3017221021
    FEI Number
    3017221021
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RM408, Bldg A2, West Bay Smart Industrial Park,Hangkong Road, San Wei Community,Hang Cheng Street, Bao'an
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160380

    Owner / Operator

    Firm Name
    Sigowill Bio Meditech Limited
    Operator Number
    10082734
    Address
    RM408, Bldg A2, West Bay Smart Industrial Park,Hangkong Road, San Wei Community,Hang Cheng Street, Bao'an
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518100
    Country
    CN
    Correspondent
    Yang Su

    US Agent

    Business Name
    Lutech Industries
    Contact Name
    Theodore Schenberg
    Address
    3910 Industrial Blvd
    City
    Indianapolis
    State
    IN
    ZIP
    46254
    Country
    US
    Email
    [email protected]
    Phone
    631 6767432 ext. 705

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    LT-300 HD

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)