BEUDAMED
    FDA Registration Active 🇨🇳 China

    Flexi-Seal SIGNAL Fecal Management System

    Reg #: 3007285848 · FEI: 3007285848 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FLEXAN (SUZHOU) PRECISION RUBBER PRODUCTS CO., LTD.
    Registration Number
    3007285848
    FEI Number
    3007285848
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block 67,Dongjing Workshop, No.25 Dongfu Road, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150350

    Owner / Operator

    Firm Name
    FMI LLC
    Operator Number
    10052883
    Address
    500 Bond Street
    City
    Lincolnshire
    State
    IL
    Postal Code
    60069
    Country
    US
    Correspondent
    Sommer Altvater

    US Agent

    Business Name
    Flexan LLC
    Contact Name
    Sommer Altvater
    Address
    500 Bond Street
    City
    Lincolnshire
    State
    IL
    ZIP
    60069
    Country
    US
    Email
    [email protected]
    Phone
    302 3045416

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    Flexi-Seal SIGNAL Fecal Management System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)