BEUDAMED
    FDA Registration Active 🇮🇳 India

    BreastHealth-100

    Reg #: 3018553169 · FEI: 3018553169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIRAMAI HEALTH ANALYTIX
    Registration Number
    3018553169
    FEI Number
    3018553169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Niramai Health Analytix Pvt Ltd, Innova Pearl, No. 17, 5th Block, Koramangala
    City
    Bangalore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K212965

    Owner / Operator

    Firm Name
    NIRAMAI Health Analytix Pvt Ltd
    Operator Number
    10086919
    Address
    Niramai Health Analytix Pvt Ltd, Innova Pearl, No. 17, 5th Block, Koramangala
    City
    Bangalore
    State
    Karnataka
    Postal Code
    560095
    Country
    IN
    Correspondent
    Geetha Manjunath

    US Agent

    Business Name
    NIRAMAI Health Analytix
    Contact Name
    Sabine Hairabedian
    Address
    22 Cambridge Lane, Manhasset
    City
    Manhasset
    State
    NY
    ZIP
    11030
    Country
    US
    Email
    [email protected]
    Phone
    516 3041980

    Products

    Device Name Product Code
    System, Telethermographic (Adjunctive Use) LHQ

    Proprietary Names

    BreastHealth-100 MammoBuddy SMILE-100 System

    Establishment Types

    Manufacture Medical Device