BEUDAMED
    FDA Registration Active 🇺🇾 Uruguay

    ReActiv8 System

    Reg #: 3010326622 · FEI: 3010326622 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Centro de Construccion de Cardioestimuladores del Uruguay S.A.
    Registration Number
    3010326622
    FEI Number
    3010326622
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    General Paz 1363
    City
    Montevideo
    Country
    UY

    Regulatory Submissions

    PMA Number
    P190021

    Owner / Operator

    Firm Name
    GREATBATCH MEDICAL
    Operator Number
    9035261
    Address
    2300 Berkshire Lane N, --
    City
    Plymouth
    State
    MN
    Postal Code
    55441
    Country
    US

    Products

    Device Name Product Code
    Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief QLK

    Proprietary Names

    ReActiv8 System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)