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Arrow International C.R. a.s.

Czech Republic · Zdar Nad Sazavou Vyso?Ina

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 4 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

80listed device types

Class I 22Class II 58Class III 0

plus 426 registration records and 48 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class II 16

37 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

44active device licences

Class II 35Class III 4Class IV 5

133 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

United States426 registration records, 48 510(k), 0 PMA, 9 excluded

Brazil16 confirmed, 1 excluded

Canada44 confirmed, 0 excluded

Manufacturer names merged into this page: Arrow International CR, a.s. · Arrow International C.R. a.s. · Arrow International LLC (subsidiary of Teleflex Incorporated) · Arrow International, LLC (subsidiary of Teleflex Incorporated) · ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) · ARROW INTERNATIONAL LLC SUBSIDIARY OF TELEFLEX INCORPORATED

FDA 510(k) clearances by year

12003

32004

12006

12007

22008

72012

52013

22014

32015

62016

32017

12018

32019

22020

32022

22023

12024

22025

FDA listed device types

showing 8 of 80

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 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250542	AC3 Range Intra-Aortic Balloon Pump	2025-03-26
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
BR	10150470150	CONJUNTO PARA DRENAGEM URETERAL RUSCH	Class II
BR	80312279055	Cateter Intravenoso de Dois Lúmens Twin Cath	Class II
BR	80312279062	SAC Cateter Venoso / Arterial Periférico	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 C.R. a.s.

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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