BEUDAMED
    FDA Registration Active 🇮🇳 India

    MMT-5100JA Simplera Sensor 5PK

    Reg #: 3018094310 · FEI: 3018094310 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    2

    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
    P160007

    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
    Sensor, Glucose, Invasive, Non-Adjunctive PQF
    Sensor, Glucose, Invasive MDS

    Proprietary Names

    MMT-5100JA Simplera Sensor 5PK MMT-5101W Simplera System Sensor Starter Kit MMT-5100JC Simplera Sensor 5PK MMT-5100JPA Simplera Sensor Pharmacy 5PK MMT-7020MLA Guardian Sensor (3) 5pk MMT-7715 Charger, Replacement (Grey) MMT-7736L Tester 2pk MMT-7705 MiniLink Transmitter Charger, Replacement (Blue) MMT-8401 Simplera App Android MMT-5101PN Simplera Sensor Kit Pharmacy 5PK MMT-5100JD Simplera Sensor 1PK MMT-5120C Simplera Sync CSS7200 Guardian Connect App MMT-7512 One-press Serter MMT-7020 Enlite 3 Sensor 5pk MMT-7821L Guardian Connect Transmitter MMT-5100JB Simplera Sensor 1PK MMT-8400 Simplera App iOS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198