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CONVATEC LIMITED

United Kingdom of Great Britain and Northern Ireland · Greensboro

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. 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

pendingnot queried

USUnited StatesFDA openFDA

70listed device types

Class I 44Class II 25Class III 0unclassified 1

plus 130 registration records and 29 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

75registered devices

Class I 45Class II 30

99 including historic records

SASaudi ArabiaSFDA

22registered imported devices

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

CACanadaMDALL

18active device licences

Class II 15Class IV 3

51 including historic records

TWTaiwanTFDA

41valid device licences

Class I 22Class II 19

SGSingaporeHSA SMDR

29device registrations

CLASS B 8CLASS C 16CLASS D 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

57active ARTG entries

Class I 28Class III 12IIa 3IIb 8Class Is (sterile) 6

HKHong KongMDACS

18valid listings

Class II 2Class III 8Class IV 8

ILIsraelAMAR

35registrations

RURussiaRoszdravnadzor

21active registrations

Class 1 10Class 2a 1Class 2b 7Class 3 3

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.

United States130 registration records, 29 510(k), 0 PMA, 9 excluded

Brazil75 confirmed, 1 excluded

Saudi Arabia22 confirmed, 0 excluded

Canada18 confirmed, 2 excluded

Manufacturer names merged into this page: CONVATEC LIMITED · ConvaTec, Inc. · CONVATEC INC. · CONVATEC, INC. · ConvaTec Limited

Business registration

Company number: 01309639
Registration status: Active
Legal form: Private Limited Company
Incorporated: 1977-04-21
Principal activity: 32500 - Manufacture of medical and dental instruments and supplies
Registered address: GDC FIRST AVENUE, DEESIDE, CH5 2NU

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

FDA 510(k) clearances by year

21997

12008

12009

22010

12011

22012

12013

12014

12015

22016

22017

32018

12019

22022

12023

12024

32025

22026

FDA listed device types

showing 8 of 70

Irrigator, Ostomy 1Urinometer, Mechanical 1Nebulizer (Direct Patient Interface) 1Catheter, Retention Type, Balloon 1Device, Cystometric, Hydraulic 1Filter, Bacterial, Breathing-Circuit 1Tube, Feeding 1Catheter Care Tray 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260737	Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).	2026-08-05
US	K252943	GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women	2026-04-01
US	K250699	Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)	2025-07-01
BR	80523020078	FLEXI-SEAL PRIVACY (Protect Plus) Bolsa Coletora para Sistema Flexi-Se	Class I
BR	80523020075	GentleCath Glide Cateter Urinário Intermitente Hidrofílico	Class I
BR	80523020002	Esenta Stomahesive Pasta Preenchedora e Barreira Protetora de Pele	Class I
SA	ME0000002556SFDAA00031	Esteem +	—
SA	ME0000002556SFDAA00059	Combihesive Natura	—
CA	5453	UROLOGICAL CATHETERS	Class II
CA	63818	ABVISER INTRA-ABDOMINAL PRESSURE MONITORING KIT	Class II
CA	66232	ESTEEM SYNERGY STERILE POST OPERATIVE SYSTEM	Class II