BEUDAMED
    FDA Registration Active 🇮🇳 India

    ROMSONS INTERNATIONAL

    Reg #: 9613418 · FEI: 3001044237 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    23

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    Registration Details

    Registration Name
    ROMSONS INTERNATIONAL
    Registration Number
    9613418
    FEI Number
    3001044237
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit-II 59J(C) & 9, Noida Special Economic Zone, Noida Dadri Road, Phase-II,NOIDA
    City
    NOIDA Uttar Pradesh
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K223499

    Owner / Operator

    Firm Name
    ROMSONS INTERNATIONAL
    Operator Number
    9041650
    Address
    UNIT- II 59J(C) & 9,Noida Special Economic Zone,, Noida Dadri Road,Phase-II,
    City
    NOIDA
    State
    Uttar Pradesh
    Postal Code
    201305
    Country
    IN
    Correspondent
    KISHORE N KHANNA

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd, Great Neck,
    City
    Allenwood
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    570 1516482

    Products

    Device Name Product Code
    Device, Incontinence, Urosheath Type, Sterile EXJ
    Catheters, Suction, Tracheobronchial BSY
    Trap, Sterile Specimen BYZ
    Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW
    Uroflowmeter EXY
    Catheter, Nasal, Oxygen BZB
    Tubing, Pressure And Accessories BYX
    Bag, Drainage, With Adhesive, Ostomy FON
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Electrode, Electrocardiograph DRX
    Mask, Oxygen, Non-Rebreathing KGB
    Mask, Oxygen BYG
    Cannula, Nasal, Oxygen CAT
    Bottle, Collection, Breathing System (Calibrated) CBD
    Airway, Oropharyngeal, Anesthesiology CAE
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Disinfectant, Medical Devices LRJ
    Airway, Nasopharyngeal BTQ
    Clamp HXD
    Stopcock, I.V. Set FMG
    Mask, Oxygen, Low Concentration, Venturi BYF
    Catheter And Tip, Suction JOL
    Tube, Aspirating, Flexible, Connecting BYY

    Proprietary Names

    Romsons Male Cath GS-1010 Romsons Suction Catheter - FT GS-2022 Romsons Suction Catheter - Plain GS-2006 Romsons Suction Catheter - TC GS-2030 Romsons Mucus Extractor with & without Filter , GS-5018W , GS-5018F Romsons Leg Bag GS-1024 Romsons Urometers , GS-1018-500 & GS-1018-250 Romsons Oxy Cath GS-2014 Oxygen Supply Tube Romsons Colobag GS-4020 ROMSONS CATALOGUE R Romsons Nelaton Catheter GS-1004 Romsons Female Catheter GS-1004F Romsons Romsons Hi-Mask GS-2044 Romsons Flexi Mask GS-2020 OXY-SET CATALOGUE R Romsons Oxy Set GS-2016 Romsons Romoseal GS-5020 , GS-5031 & GS-5032 Romsons Guedel Airways GS-2012 Romsons Peadiatric Urine Collecting Bag GS-1062 Romsons Urine Collecting Bags , GS-1020A ,GS-1020B , GS-1020T , GS1020AH , GS-1020R4 , GS-1020R5 Alcohol Swab Romsons Nasopharyngeal Airway GS-2034 Romsons Cath Clamp GS-1014 Three Way Stop cock Exxacta Bi Valve Romsons Oxy Lock GS-2038 Romsons Yankaur Suction Set GS-5016 Romsons Yankaur Suction Handle GS-5014C & GS-5014S Romsons Yankaur Suction Tips GS-5014 Romsons Vaccu Suck Suction Set , GS-5016C & GS-5016S Romsons Suction Connecting Tubes , GS-5017 & GS-5019

    Establishment Types

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