BEUDAMED
    FDA Registration Active 🇦🇷 Argentina

    Tecme SA

    Reg #: 3009302812 · FEI: 3009302812 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Tecme SA
    Registration Number
    3009302812
    FEI Number
    3009302812
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Av. Circunvalacion (N-O) Agustin Tosco 3040
    City
    Cordoba
    Country
    AR

    Regulatory Submissions

    510(k) Number
    K101401

    Owner / Operator

    Firm Name
    Tecme S.A.
    Operator Number
    10034919
    Address
    Av. Circunvalacion (N-O) Agustin Tosco 3040
    City
    Cordoba
    State
    AR-X
    Postal Code
    X5008HJY
    Country
    AR
    Correspondent
    Ernesto M Mana Escuti

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    TECME 33XXRXV Ventilator Model Neumovent GraphNet GraphNet Neo GraphNet Advance GraphNet TS Neumovent GraphNet Ts Neumovent GraphNet Neo Neumovent Schiller GraphNet Neo Neumovent GraphNet Advance Neumovent Schiller GraphNet Ts Neumovent Schiller GraphNet Advance

    Establishment Types

    Manufacture Medical Device