BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    M-Drain Percutaneous Introducer System

    Reg #: 3007146453 · FEI: 3007146453 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MERMAID MEDICAL A/S
    Registration Number
    3007146453
    FEI Number
    3007146453
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Frydensbergvej 25
    City
    Stenloese Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K071330

    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
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    M-Drain Percutaneous Introducer System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Manufacture Medical Device