BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    aBSI

    Reg #: 3010146120 · FEI: 3010146120 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EXINI DIAGNOSTICS AB
    Registration Number
    3010146120
    FEI Number
    3010146120
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ideon Science Park, Scheelevagen 27
    City
    LUND Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K191262

    Owner / Operator

    Firm Name
    EXINI Diagnostics AB
    Operator Number
    10042079
    Address
    Ideon Science Park, Scheelevagen 27
    City
    LUND
    State
    Skane
    Postal Code
    SE-223 70
    Country
    SE
    Correspondent
    Aseem Anand

    US Agent

    Business Name
    Progenics Pharmaceuticals Inc.
    Contact Name
    Karl Sjoestrand
    Address
    201 Burlington Rd South Building Bedford
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US
    Email
    [email protected]
    Phone
    800 2993431

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    aBSI EXINI Bone

    Establishment Types

    Manufacture Medical Device