BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Oximeter

    Reg #: 3010526986 · FEI: 3010526986 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PROTOTAL-PDS AB
    Registration Number
    3010526986
    FEI Number
    3010526986
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hantverksgatan 2
    City
    Gotene Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K063752

    Owner / Operator

    Firm Name
    Prototal-PDS AB
    Operator Number
    10045504
    Address
    Hantverksgatan 2
    City
    Gotene
    State
    Vastra Gotaland
    Postal Code
    53333
    Country
    SE
    Correspondent
    Micael Wastefors

    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
    Oximeter DQA
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    Oximeter

    Establishment Types

    Manufacture Medical Device