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Data / Medical devices / India / Romsons International

Romsons International: FDA-registered device maker in NOIDA Uttar Pradesh, India, 1 510(k) clearance

Romsons International is registered with the FDA (registration 9613418) in NOIDA Uttar Pradesh, India. It lists 23 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 21, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Romsons International
FDA registration number
9613418
FEI number
3001044237
Address
Unit-II 59J(C) & 9, Noida Special Economic Zone Noida Dadri Road, Phase-II,NOIDA, NOIDA Uttar Pradesh, India, 201305
Owner or operator
ROMSONS INTERNATIONAL (9041650)
Roles
Exporter to the US, Manufacturer
First device listed
May 31, 2000
Registered through
2026
Brand names listed
Alcohol Swab, Bi Valve, Exxacta, OXY-SET CATALOGUE R, Oxygen Supply Tube, ROMSONS CATALOGUE R, Romsons, Romsons Cath Clamp GS-1014 and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Manufactureraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Manufactureraccessdata.fda.gov
Bottle, Collection, Breathing System (Calibrated)CBD2Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Manufactureraccessdata.fda.gov
ClampHXD1Exporter to the US, Manufactureraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Manufactureraccessdata.fda.gov
Device, Incontinence, Urosheath Type, SterileEXJ1Manufactureraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Manufactureraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Exporter to the US, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Manufactureraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Manufactureraccessdata.fda.gov
Stopcock, I.V. SetFMG2Manufactureraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov
UroflowmeterEXY2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 21, 2023K223499Three Way Stop CockFMGSubstantially EquivalentM/S Romsons Internationalaccessdata.fda.gov

Compare with other makers

Updated July 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.