BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    DI-60 with Advanced RBC Application

    Reg #: 3003630693 · FEI: 3003630693 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    CELLAVISION AB
    Registration Number
    3003630693
    FEI Number
    3003630693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Mobilvagen 12
    City
    LUND Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K171315

    Owner / Operator

    Firm Name
    CellaVision AB
    Operator Number
    9043433
    Address
    Mobilvagen 12, --
    City
    LUND
    State
    SE-NOTA
    Postal Code
    SE-22362
    Country
    SE
    Correspondent
    Charlotte - Oom

    US Agent

    Business Name
    -
    Contact Name
    Scott Dunbar
    Address
    2530 Meridian Pkwy, Suite 300, -
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    919 8064420

    Products

    Device Name Product Code
    Device, Automated Cell-Locating JOY

    Proprietary Names

    DI-60 with Advanced RBC Application CellaVision DM9600 with Advanced RBC Application CellaVision DM96 and DM1200 with Advanced RBC Application

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device