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TELEFLEX MEDICAL EUROPE LIMITED

Ireland

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Russia — 6 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

549listed device types

Class I 364Class II 176Class III 3unclassified 6

plus 950 registration records and 48 510(k), 15 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

140registered devices

Class I 20Class II 120

154 including historic records

SASaudi ArabiaSFDA

15registered imported devices

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

CACanadaMDALL

132active device licences

Class II 118Class III 8Class IV 6

320 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

7active registrations

Class 2a 3Class 2b 2Class 3 2

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 States950 registration records, 48 510(k), 15 PMA, 21 excluded

Brazil140 confirmed, 3 excluded

Saudi Arabia15 confirmed, 0 excluded

Canada132 confirmed, 3 excluded

Manufacturer names merged into this page: Teleflex Medical LLC · Teleflex Medical Sdn. Bhd. · Teleflex Medical Inc. · TELEFLEX MEDICAL · TELEFLEX MEDICAL SDN. BHD. · TELEFLEX MEDICAL LLC

FDA 510(k) clearances by year

22003

42004

12005

42006

32007

12008

12010

12012

32013

22016

12017

52018

22019

22020

12021

12022

32023

32024

32025

52026

FDA listed device types

showing 8 of 549

Knife, Nasal 1Crusher, Spur, Colostomy 1Gag, Mouth 1Tamp 1Attachment, Eyepiece, For Insertion Of Prescription Lens 1Condenser, Heat And Moisture (Artificial Nose) 1Accessories, Catheter 1Tourniquet, Nonpneumatic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262056	Rusch Latex Gold Foley Catheter	2026-08-05
US	K261988	Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture	2026-07-09
US	K252643	Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled	2026-05-15
BR	10150470130	TUBO EM T-KEHR RUSCH	Class II
BR	10150470235	CATETER URETERAL RUSCH	Class II
BR	10150470211	DRENO DE SUCCAO CAPILAR TIPO PENROSE RUSCH	Class II
SA	ME0000003656SFDAA00048	Weckstat Skin Staple Remover	—
SA	ME0000003656SFDAA00053	Universal Ventilator Set, w/ Water Traps, Long Length	—
CA	99048	HUDSON RCL COMFORT FLO PLUS CANNULA	Class II
CA	99163	HUDSON RCI TRACHEOSTOMY ADAPTOR	Class II
CA	5930	MALECOT AND PEZZER CATHETERS	Class II

TELEFLEX MEDICAL EUROPE LIMITED

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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