BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    EPISURF OPERATIONS AB

    Reg #: 3015341893 · FEI: 3015341893 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    EPISURF OPERATIONS AB
    Registration Number
    3015341893
    FEI Number
    3015341893
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Karlavagen 60
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K221048

    Owner / Operator

    Firm Name
    Episurf Operations AB
    Operator Number
    10087531
    Address
    Karlavagen 60
    City
    Stockholm
    State
    SE-AB
    Postal Code
    11449
    Country
    SE
    Correspondent
    Ylva Bonde

    Products

    Device Name Product Code
    System, Digital Image Communications, Radiological LMD
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR

    Proprietary Names

    EpisurfView Femoral Epidummy Patellar Epidummy Episealer® Patellofemoral System Patellar Adjustment Socket Femoral Adjustment Socket Femoral Drilling Socket Patellar Epiguide Patellar Component Femoral Epidrill Femoral Epiguide Femoral Component Femoral Epimandrel Patellar Epimandrel Patellar Epidrill

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility