BEUDAMED
    FDA Registration Active 🇨🇳 China

    DELTAWAVE Nasal Pillows System

    Reg #: 3038131744 · FEI: 3038131744 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    XIAMEN BETTER SILICONE RUBBER CO., LTD
    Registration Number
    3038131744
    FEI Number
    3038131744
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F, No. 331,Siming Park, Industry cluster zone, Tong'an District
    City
    Xiamen
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233415

    Owner / Operator

    Firm Name
    Xiamen Better Silicone Rubber Co., Ltd
    Operator Number
    10093539
    Address
    1F, No. 331,Siming Park, Industry cluster zone, Tong'an District
    City
    Xiamen
    State
    CN-NOTA
    Postal Code
    361100
    Country
    CN

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr Ne
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

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

    Proprietary Names

    DELTAWAVE Nasal Pillows System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)