BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Cerebral Tissue Monitoring System

    Reg #: 3003733874 · FEI: 3003733874 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    M DIALYSIS AB
    Registration Number
    3003733874
    FEI Number
    3003733874
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hammarby Fabriksvag 43
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K071984

    Owner / Operator

    Firm Name
    M Dialysis AB
    Operator Number
    9010619
    Address
    Hammarby Fabriksvag 43, --
    City
    Stockholm
    State
    SE-NOTA
    Postal Code
    120 30
    Country
    SE

    US Agent

    Business Name
    M Dialysis Inc.
    Contact Name
    Kelly Nashawaty
    Address
    73 Princeton Street, Suite 302
    City
    North Chelmsford
    State
    MA
    ZIP
    01863
    Country
    US
    Email
    [email protected]
    Phone
    978 7103296

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    Cerebral Tissue Monitoring System

    Establishment Types

    Manufacture Medical Device