BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CETRO AMERICA

    Reg #: 3004167720 · FEI: 3004167720 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    CETRO AMERICA
    Registration Number
    3004167720
    FEI Number
    3004167720
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    33 Charles Street
    City
    Meriden
    State
    CT
    ZIP
    06450
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050826

    Owner / Operator

    Firm Name
    CETRO AMERICA
    Operator Number
    9057995
    Address
    33 Charles Street
    City
    Meriden
    State
    CT
    Postal Code
    06450
    Country
    US
    Correspondent
    MAYA - CIANCIOLO

    Products

    Device Name Product Code
    System, Monitoring, Perinatal HGM
    Electrode, Circular (Spiral), Scalp And Applicator HGP

    Proprietary Names

    ULTRASONIC Transducer Model 8031012 TOCO Transducer Model 8032026 ULTRASONIC Transducer Model 8031014 ULTRASONIC Transducer Model 8031039 ULTRASONIC Transducer Model 8031013 ULTRASONIC Transducer Model 8031017 TOCO Transducer Model 8032025 TOCO Transducer Model 8032009 ULTRASONIC Transducer Model 8031010 ULTRASONIC Transducer Model 8031040 TOCO Transducer Model 8032010 TOCO Transducer Model 8032008 TOCO Transducer Model 8032007 ULTRASONIC Transducer Model 8031011

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility