BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Patellar Epidummy

    Reg #: 9610569 · FEI: 3002806287 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MIKROLAB STOCKHOLM AB
    Registration Number
    9610569
    FEI Number
    3002806287
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kung Hans Vag 3
    City
    Sollentuna Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K221048

    Owner / Operator

    Firm Name
    Mikrolab Stockholm AB
    Operator Number
    10087767
    Address
    Kung Hans Vag 3
    City
    Sollentuna
    State
    Stockholm
    Postal Code
    19268
    Country
    SE
    Correspondent
    Marina Lundin

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR

    Proprietary Names

    Patellar Epidummy Patellar Epimandrel Femoral Epimandrel Femoral Drilling Socket Patellar Epiguide Femoral Epidummy Femoral Epiguide Femoral Adjustment Socket Patellar Adjustment Socket

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)