BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Redsense home use

    Reg #: 3006948863 · FEI: 3006948863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    REDSENSE MEDICAL AB
    Registration Number
    3006948863
    FEI Number
    3006948863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Storgatan 36
    City
    Halmstad Halland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K092955

    Owner / Operator

    Firm Name
    Redsense Medical AB
    Operator Number
    10025092
    Address
    Storgatan 36
    City
    Halmstad
    State
    Halland
    Postal Code
    302 43
    Country
    SE
    Correspondent
    Ann-Marie Eriksson

    US Agent

    Business Name
    Redsense Medical Inc
    Contact Name
    Jane Hurst
    Address
    385 Garrisonville RD Ste 113
    City
    Stafford
    State
    VA
    ZIP
    22554
    Country
    US
    Email
    [email protected]
    Phone
    937 2141771

    Products

    Device Name Product Code
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX

    Proprietary Names

    Redsense home use

    Establishment Types

    Manufacture Medical Device