BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CRITICARE TECHNOLOGIES, INC.

    Reg #: 3012238587 · FEI: 3012238587 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    CRITICARE TECHNOLOGIES, INC.
    Registration Number
    3012238587
    FEI Number
    3012238587
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    333 Strawberry Field Rd, Suite 11
    City
    Warwick
    State
    RI
    ZIP
    02886
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091050

    Owner / Operator

    Firm Name
    Criticare Technologies, Inc.
    Operator Number
    10051461
    Address
    333 Strawberry Field Rd, Suite 11
    City
    Warwick
    State
    RI
    Postal Code
    02886
    Country
    US
    Correspondent
    John Haefele

    Products

    Device Name Product Code
    Oximeter DQA
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Detector And Alarm, Arrhythmia DSI
    Monitor, St Segment With Alarm MLD
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    eQuality nGenuity Vitalcare / eQuality eVision Poet IQ / nCompass

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device