BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Medela ® THOPAZ+

    Reg #: 3002807523 · FEI: 3002807523 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDELA AG
    Registration Number
    3002807523
    FEI Number
    3002807523
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LAETTICHSTRASSE 4B
    City
    BAAR Zug
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K141553

    Owner / Operator

    Firm Name
    MEDELA AG
    Operator Number
    8030974
    Address
    LAETTICHSTRASSE 4b, --
    City
    BAAR
    State
    CH-NOTA
    Postal Code
    CH-6340
    Country
    CH

    US Agent

    Business Name
    Medela LLC
    Contact Name
    Tom Cuzman
    Address
    1101 Corporate Dr.
    City
    McHenry
    State
    IL
    ZIP
    60050
    Country
    US
    Email
    [email protected]
    Phone
    815 3493790

    Products

    Device Name Product Code
    Pump, Portable, Aspiration (Manual Or Powered) BTA

    Proprietary Names

    Medela ® THOPAZ+

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device