BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    PeriGen Solutions Ltd.

    Reg #: 9615396 · FEI: 3002687025 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PeriGen Solutions Ltd.
    Registration Number
    9615396
    FEI Number
    3002687025
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Azriel Rishonim, 10th Floor, Sderot Nim2, Rishon LeTziyon
    City
    Rishon LeTziyon Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K040788

    Owner / Operator

    Firm Name
    PeriGen, Inc.
    Operator Number
    10030146
    Address
    100 Regency Forest Drive, Suite 200
    City
    Cary
    State
    NC
    Postal Code
    27518
    Country
    US

    US Agent

    Business Name
    Perigen Inc.
    Contact Name
    Matthew Sappern
    Address
    100 Regency Forest Drive, Suite 200
    City
    Cary
    State
    NC
    ZIP
    27518
    Country
    US
    Email
    [email protected]
    Phone
    984 2094250

    Products

    Device Name Product Code
    System, Monitoring, Perinatal HGM

    Proprietary Names

    PeriCALM CheckList PeriWatch Cues PeriCALM Patterns PeriGen Visual Cueing PeriWatch Curve PeriWatch Vigilance Curve PeriCALM Curve PeriGen Decision Support Technologies PeriCALM Patterns 3 HPC Workflow Manager HPC Surveillance and Archival PeriWatch Vigilance HUB PeriCALM Tracings PeriCALM Plus

    Establishment Types

    Manufacture Medical Device