BEUDAMED
    FDA Registration Active 🇮🇳 India

    MMT-5120 Simplera Sync sensor

    Reg #: 3018094310 · FEI: 3018094310 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medtronic Engineering and Innovation Center (MEIC)
    Registration Number
    3018094310
    FEI Number
    3018094310
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BSR Tech Park, Survey No.135, 138, 141 & 142 Nanakramguda Main Road
    City
    Hyderabad
    Country
    IN

    Regulatory Submissions

    PMA Number
    P160017

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    MEDTRONIC, INC.
    Contact Name
    Tania Pearson
    Address
    3576 Unocal Pl
    City
    Santa Rosa
    State
    CA
    ZIP
    95403
    Country
    US
    Email
    [email protected]
    Phone
    916 8138456

    Products

    Device Name Product Code
    Automated Insulin Dosing Device System, Single Hormonal Control OZP

    Proprietary Names

    MMT-5120 Simplera Sync sensor MMT-7512 One-press Serter MMT-7715 Charger, Replacement (Grey) MMT-1760 MiniMed 670G Insulin Pump Kit MMT-7810 Guardian Link 3 Transmitter Kit (GST3C) MMT-7811 Guardian Link 3 Transmitter (GST3C) MMT-7020 Enlite 3 Sensor 5pk MMT-7736 Tester 2pk MMT-1780 MiniMed 670G Insulin Pump MMT-7910NA Guardian Link (3) Transmitter Kit (GST5C) MMT-7911NA Guardian Link (3) Transmitter (GST5C) MMT-1880 MiniMed 770G Insulin Pump MMT-1890 MiniMed 770G Insulin Pump Kit MG/DL MMT-1884 MiniMed 780G Insulin Pump MMT-1884L MiniMed 780G Insulin Pump MMT-7040 Guardian Sensor 4 MMT-7841 Guardian 4 Transmitter MMT-1894 MiniMed 780G Insulin Pump Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198