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ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)

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✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

55listed device types

Class I 12Class II 43Class III 0

plus 251 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

20 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

45active device licences

Class II 35Class III 4Class IV 6

134 including historic records

TWTaiwanTFDA

7valid device licences

Class II 6Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

45active ARTG entries

Class III 30IIa 6IIb 8Class Is (sterile) 1

HKHong KongMDACS

8valid listings

Class II 2Class IV 6

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States251 registration records, 27 510(k), 0 PMA, 16 excluded

Brazil3 confirmed, 10 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada45 confirmed, 3 excluded

Manufacturer names merged into this page: Arrow International LLC (subsidiary of Teleflex Incorporated) · Arrow International, LLC (subsidiary of Teleflex Incorporated) · Arrow International, LLC (subsidiary of Teleflex, Incorporated) · ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) · HOTSPUR TECHNOLOGIES, INC. SUBSIDIARY OF TELEFLEX MEDICAL · ARROW INTERNATIONAL LLC SUBSIDIARY OF TELEFLEX INCORPORATED

Same-named companies — This database also contains companies with near-identical names: Arrow International, Inc. (A Subsidiary of Teleflex, Inc.), Arrow International, Inc (Subsidiary of Teleflex I. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

42012

32013

22014

42015

62016

12017

12018

12019

32022

12024

12025

FDA listed device types

showing 8 of 55

Electrode, Needle 1Peripheral Catheter Insertion Kit 1Catheter, Hemodialysis, Non-Implanted 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Stylet, Catheter 1Kit, Repair, Catheter, Hemodialysis 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Percutaneous Atrial Catheter Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243599	Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)	2025-03-14
US	K242281	Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)	2024-12-20
US	K213855	Arrow Pressure Injectable Midline Catheter	2022-09-02
BR	80312279055	Cateter Intravenoso de Dois Lúmens Twin Cath	Class II
BR	80312279062	SAC Cateter Venoso / Arterial Periférico	Class II
BR	80312279075	Cateter Arterial Radial Quickflash	Class II
CA	683	FLOW-THROUGH INJECTATE PROBE	Class II
CA	709	THERMO-PACE HANDS-OFF HEPARIN COATED THERMODILUTION CATHETER	Class IV
CA	722	INTRA-AORTIC BALLOON PUMP	Class IV

ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)

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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