BEUDAMED
    FDA Registration Active 🇫🇷 France

    Leucolab LCG2 Leukoreduction Systems for AS-1 And AS-3 Red Blood Cells

    Reg #: 3003775072 · FEI: 3003775072 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IONISOS
    Registration Number
    3003775072
    FEI Number
    3003775072
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZI
    City
    CHAUMESNIL Grand Est
    Country
    FR

    Regulatory Submissions

    510(k) Number
    BK120071

    Owner / Operator

    Firm Name
    EPIONE BIDCO
    Operator Number
    10042490
    Address
    415 allee de Frenes, bat Squale
    City
    LIMONEST
    State
    Rhone
    Postal Code
    69760
    Country
    FR
    Correspondent
    Alexandra Basset

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7131159

    Products

    Device Name Product Code
    Microfilter, Blood Transfusion CAK

    Proprietary Names

    Leucolab LCG2 Leukoreduction Systems for AS-1 And AS-3 Red Blood Cells Leukoreduction Systems For AS-1, AS-3 And AS-5 Red Blood Cells Leucolab LCG2 Leukoreduction Systems For AS-1 Red Blood Cells, Leucolab LCG2

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)