BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    MA1100-PM Mistral Air Plus 115V-SYK

    Reg #: 3004491421 · FEI: 3004491421 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AIM B.V.
    Registration Number
    3004491421
    FEI Number
    3004491421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Boschstraat 6
    City
    Brunssum Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K101705

    Owner / Operator

    Firm Name
    AIM B.V.
    Operator Number
    10046555
    Address
    Boschstraat 6
    City
    Brunssum
    State
    NL-NOTA
    Postal Code
    6442 PB
    Country
    NL

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    MA1100-PM Mistral Air Plus 115V-SYK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)