BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    PROTOTAL Sweden AB

    Reg #: 3010526986 · FEI: 3010526986 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    PROTOTAL Sweden AB
    Registration Number
    3010526986
    FEI Number
    3010526986
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Instrumentvaegen 6
    City
    Jonkoping
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K063752

    Owner / Operator

    Firm Name
    Prototal Sweden AB
    Operator Number
    10045504
    Address
    Instrumentvaegen 6
    City
    Joenkoeping
    State
    Jonkoping
    Postal Code
    SE-553 02
    Country
    SE
    Correspondent
    Anita Olsson

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Catheters, Suction, Tracheobronchial BSY
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter DQA
    Dilator, Rectal FFP

    Proprietary Names

    Nose Frida Oximeter Frida Baby

    Establishment Types

    Manufacture Medical Device