BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Micro Well Group Culture Dish,9-well Micro Well Group Culture Dish,16-well

    Reg #: 3012416874 · FEI: 3012416874 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Elos Medtech Skara AB
    Registration Number
    3012416874
    FEI Number
    3012416874
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hasthagsgatan 2
    City
    Skara Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K150756

    Owner / Operator

    Firm Name
    Elos Medtech Skara AB
    Operator Number
    10051299
    Address
    Hasthagsgatan 2
    City
    Skara
    State
    Vastra Gotaland
    Postal Code
    S-53237
    Country
    SE
    Correspondent
    Maria Skold

    US Agent

    Business Name
    ONYX MEDICAL CORPORATION
    Contact Name
    JODIE GILMORE
    Address
    1800 North Shelby Oaks Drive
    City
    Memphis
    State
    TN
    ZIP
    38134
    Country
    US
    Email
    [email protected]
    Phone
    901 3236699

    Products

    Device Name Product Code
    Labware, Assisted Reproduction MQK

    Proprietary Names

    Micro Well Group Culture Dish,9-well Micro Well Group Culture Dish,16-well Micro Well Group Culture Dish, 16-well

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)