Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613418

FEI Number

3001044237

Entity Name

ROMSONS INTERNATIONAL

City/State/Country

NOIDA Uttar Pradesh, IN

Establishment Address

Unit-II 59J(C) & 9, Noida Special Economic Zone, Noida Dadri Road, Phase-II,NOIDA, NOIDA Uttar Pradesh 201305, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ROMSONS INTERNATIONAL (Owner Number: 9041650)

Owner / Operator Contact Address

UNIT- II 59J(C) & 9,Noida Special Economic Zone,, Noida Dadri Road,Phase-II,, NOIDA, IN-UP 201305, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-01-23
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2000-05-31
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2013-01-23
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-01-23
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2013-01-23
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2013-01-23
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2024-12-23
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2013-01-23
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2000-05-31
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2019-12-18
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2013-01-23
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2013-01-23
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2000-05-31
CBD	Bottle, Collection, Breathing System (Calibrated)	General Hospital	Class 2	880.6740	2013-01-23
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2013-01-23

Official Correspondent

KISHORE KHANNA

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (570) 1516482

Related Public Records

Same Entity

ROMSONS INTERNATIONAL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K772144	Medline Industries, Inc.	CATHETER, DISP., EXTERNAL, MALE	1977-11-28
K945628	Mentor Corp.	CLEAR ADVANTAGE II	1995-07-06
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Similar Registrations

Registration Number	Establishment Name	Location
3003965134	RECE INTERNATIONAL CORP.	Miami Lakes, FL, US
1423537	Cardinal Health 200, LLC	Waukegan, IL, US
3001650535	Suzhou Meccan Import and Export Corp.	Suzhou Jiangsu, CN
2938651	MAYER LABORATORIES	Berkeley, CA, US
9612030	Cardinal Health (Kenmex Medical Specialties)	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613418. Last updated year: 2026. Please use registration number 9613418 when referencing this establishment in official correspondence.