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Romsons International

✓ Record-verifiedregistrations found in 7 marketsEU SRN IN-MF-000024594

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Australia — 7 overseas markets. EU UDI-DI records ≥45, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥45UDI-DI device records

Class IIa 45

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

23listed device types

Class I 15Class II 8Class III 0

plus 23 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

14registered device records

Class I 7Class IIa 7

BRBrazilANVISA

25registered devices

Class I 7Class II 18

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

35active ARTG entries

Class I 1IIa 30Class Is (sterile) 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,703 raw hits, 255 excluded, 45 confirmed. Large result set — only the first 300 verified

United States23 registration records, 1 510(k), 0 PMA

United Kingdom14 confirmed, 1 excluded

Brazil25 confirmed, 0 excluded

Manufacturer names merged into this page: ROMSONS INTERNATIONAL · ROMSONS INTERNACIONAL · Romsons Internacional

Regulatory identity

EU manufacturer SRN: IN-MF-000024594
EU authorised representative: Obelis s.a.
UK responsible person: CMC Medical Devices LTD

Business registration

LEI: 335800KKSE4VVTGQHU56
Registration status: Active
Legal form: Partnership Firm
Incorporated: 1992-03-31
Registered address: PLOT NO. 59-J C, NOIDA SPECIAL ECONOMIC ZONE, GAUTAM BUDDHA NAGAR,, NOIDA, 201305
Registration authority: GST Portal, no. 09AABFR0251R1ZW
Registry record updated: 2026-07-28

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12023 · K223499

FDA listed device types

showing 8 of 23

Mask, Oxygen, Low Concentration, Venturi 1Disinfectant, Medical Devices 1Mask, Oxygen, Non-Rebreathing 1Clamp 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Bag, Urine Collection, Leg, For External Use, Non-Sterile 1Bag, Drainage, With Adhesive, Ostomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08902120400413	RYLE'S TUBE 6FG	Class IIa
EU	08902120400420	RYLE'S TUBE 8FG	Class IIa
EU	08902120400437	RYLE'S TUBE 10FG	Class IIa
EU	08902120400444	RYLE'S TUBE 12FG	Class IIa
UK	10098	Ampsnap Vial Opening Device	Class I
UK	11301	Bile Bag	Class I
UK	65196	Mid Stream Urine Collection Set	Class I
US	K223499	Three Way Stop Cock	2023-07-21
BR	82393789002	Cânula Intravenosa	Class II
BR	82393780013	Safsite	Class I
BR	82393780014	Bolsa de Coleta de Urina	Class I

Romsons International

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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