BEUDAMED
    FDA Registration Active 🇫🇷 France

    Holter reader

    Reg #: 3008159616 · FEI: 3008159616 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Sorin CRM SAS
    Registration Number
    3008159616
    FEI Number
    3008159616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4, avenue Reaumur
    City
    CLAMART Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K042002

    Owner / Operator

    Firm Name
    MicroPort CRM USA, Inc.
    Operator Number
    2182863
    Address
    5677 Airline Road, Regulatory Affairs, c/o Dwyndl Nelms
    City
    Arlington
    State
    TN
    Postal Code
    38002
    Country
    US
    Correspondent
    John - Skousen

    US Agent

    Business Name
    MICROPORT CRM USA, INC.
    Contact Name
    John Skousen
    Address
    5677 Airline Road, Regulatory Affairs, c/o John Skuosen (MicroPort CRM)
    City
    Arlington
    State
    TN
    ZIP
    38002
    Country
    US
    Email
    [email protected]
    Phone
    801 3864437

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Holter reader Easyscope Synecom Synescope Synecom HRV

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198