BEUDAMED
    FDA Registration Active 🇫🇷 France

    MANATEC

    Reg #: 1000610255 · FEI: 1000610255 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MANATEC
    Registration Number
    1000610255
    FEI Number
    1000610255
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 bis Rue Jacob Courant
    City
    Poissy Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K140102

    Owner / Operator

    Firm Name
    Manatec SARL
    Operator Number
    10028447
    Address
    21 rue du Stade
    City
    Petit Ebersviller
    State
    FR-NOTA
    Postal Code
    57730
    Country
    FR
    Correspondent
    Benoit Bosquet

    US Agent

    Business Name
    Eastern Rail Systems
    Contact Name
    James Gunnerson
    Address
    2014 Ford Rd Ste G
    City
    Bristol
    State
    PA
    ZIP
    19007
    Country
    US
    Email
    [email protected]
    Phone
    215 8269980

    Products

    Device Name Product Code
    Plethysmograph, Impedance DSB

    Proprietary Names

    PF07 Q-Link PhysioFlow Q-Link PhysioFlow System PF07 Enduro PhysioFlow Enduro

    Establishment Types

    Manufacture Medical Device