BEUDAMED
    FDA Registration Active 🇺🇸 United States

    M-Drain

    Reg #: 3027260597 · FEI: 3027260597 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Mermaid Medical A/S (FL Site)
    Registration Number
    3027260597
    FEI Number
    3027260597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8033 Cooper Creek Blvd Ste 106
    City
    University Park
    State
    FL
    ZIP
    34201
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033862

    Owner / Operator

    Firm Name
    Mermaid Medical
    Operator Number
    10045264
    Address
    8033 Cooper Creek Blvd, Unit 106
    City
    University Park
    State
    FL
    Postal Code
    34201
    Country
    US
    Correspondent
    Matthew Genzman

    Products

    Device Name Product Code
    Catheter, Nephrostomy LJE
    Stents, Drains And Dilators For The Biliary Ducts FGE

    Proprietary Names

    M-Drain

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility