BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZOE MEDICAL, INC.

    Reg #: 3003294644 · FEI: 3003294644 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    ZOE MEDICAL, INC.
    Registration Number
    3003294644
    FEI Number
    3003294644
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    460 BOSTON ST.
    City
    TOPSFIELD
    State
    MA
    ZIP
    01983
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093802

    Owner / Operator

    Firm Name
    Zoe Medical, Inc
    Operator Number
    9041242
    Address
    460 BOSTON ST., --
    City
    Topsfield
    State
    MA
    Postal Code
    01983
    Country
    US
    Correspondent
    Bengt Hermanrud

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Oximeter DQA
    Electrocardiograph DPS
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

    Proprietary Names

    Ultraview DM3 Schiller DS20 Midmark DVSD Midmark IQvitals Nightingale PPM3 Nightingale MPC Nightingale Monitoring System PPM3 Nightingale PPM2 Nightingale PPM well@home system well@home2 system Nightingale PHM 740 Select 91331 DM4

    Establishment Types

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