BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    M DIALYSIS AB

    Reg #: 3003733874 · FEI: 3003733874 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    M DIALYSIS AB
    Registration Number
    3003733874
    FEI Number
    3003733874
    Status
    Active
    Expiry Year
    2026
    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
    General Purpose Reagent PPM
    Catheter, Peritoneal GBW

    Proprietary Names

    Cerebral Tissue Monitoring System Reagents for Iscus flex 63 MD Catheter 40/30

    Establishment Types

    Manufacture Medical Device