BEUDAMED
    FDA Registration Active 🇫🇷 France

    898045-EEG lead yellow cup bipolar

    Reg #: 3004762958 · FEI: 3004762958 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    NISSHA MEDICAL TECHNOLOGIES SAS
    Registration Number
    3004762958
    FEI Number
    3004762958
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23-25 Boulevard de la Paix
    City
    Cergy Val-d'Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K000892

    Owner / Operator

    Firm Name
    NISSHA MEDICAL TECHNOLOGIES SAS
    Operator Number
    10032984
    Address
    400 Exchange Street
    City
    Buffalo
    State
    NY
    Postal Code
    14204
    Country
    US
    Correspondent
    Jessica Potter

    US Agent

    Business Name
    NISSHA MEDICAL TECHNOLOGIES
    Contact Name
    Jessica POTTER
    Address
    Graphic Controls d.b.a. Vermed, 400 Exchange Street
    City
    Buffalo
    State
    NY
    ZIP
    14204
    Country
    US
    Email
    [email protected]
    Phone
    716 8537500

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Burst Suppression Detection Software For Electroencephalograph ORT

    Proprietary Names

    898045-EEG lead yellow cup bipolar 898147-EEG lead green clip bipolar 898042-EEG lead blue clip bipolar 898051-EEG lead set 2, 4 ch bipolar 898038-EEG lead black (ground) clip 898152 - Customized EEG lead kit 5 898050-EEG lead set 1, 2 ch bipolar 898148-EEG lead green clip refer. 898043-EEG lead blue cup bipolar 898144-EEG lead yellow clip bipolar 898155 - Customized EEG lead kit 8 898041-EEG lead red cup bipolar 898151 - Customized EEG lead kit 4 898046-EEG lead green cup bipolar 898149-EEG lead green cup refer. 898150-EEG lead empty block 898052-EEG lead set 3, 2 ch refer. 898039-EEG lead black (ground) cup 898146-EEG lead yellow cup refer. 898154 - Customized EEG lead kit 7 898153 - Customized EEG lead kit 6 898143-EEG lead blue cup refer. 898044-EEG lead blue clip refer. 898040-EEG lead red clip bipolar 898145-EEG lead yellow clip refer.

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)