BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    IQool™ Warm System

    Reg #: 3008727520 · FEI: 3008727520 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SCANFIL ATVIDABERG AB
    Registration Number
    3008727520
    FEI Number
    3008727520
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Orsatter
    City
    Atvidaberg Ostergotland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K180375

    Owner / Operator

    Firm Name
    Scanfil Atvidaberg AB
    Operator Number
    10034507
    Address
    Orsatter
    City
    Atvidaberg
    State
    Ostergotland
    Postal Code
    59780
    Country
    SE
    Correspondent
    Karin Skullman

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    IQool™ Warm System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)