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Creagh Medical Ltd. Dba Surmodics, Inc.

Ireland · Ballinasloe

✓ Record-verifiedregistrations found in 9 markets

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

5listed device types

Class I 0Class II 4Class III 1

plus 12 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

2active device licences

Class IV 2

3 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

1registrations

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 States12 registration records, 8 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Creagh Medical Ltd. · CREAGH MEDICAL LIMITED · CREAGH MEDICAL LTD. · Creagh Medical Ltd

Same-named companies — This database also contains companies with near-identical names: CREAGH MEDICAL LIMITED, Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12010

12011

12017

12018

12020

12021

12023

12024

FDA listed device types

Catheter, Intravascular Occluding, Temporary 1Introducer, Catheter 1Catheter, Percutaneous 1Catheter, Angioplasty, Peripheral, Transluminal 1Drug-Eluting Peripheral Transluminal Angioplasty Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242419	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	2024-11-15
US	K230191	Arise UHP Dilatation Catheter	2023-03-22
US	K211044	Sublime Radial Access 018 RX Dilatation Catheter	2021-06-16
BR	10212999033	CATETER BALÃO PARA DILATAÇÃO ADVANCE SERENITY 14	Class II
BR	80312279063	CATETER BALÃO PARA DILATAÇÃO PERIFÉRICA DE ALTA PRESSÃO PASSEO-35 HP	Class II
BR	10212999029	CATETER BALÃO PARA DILATAÇÃO ADVANCE SERENITY 18	Class II
CA	79609	OPTIMUS PTA BALLOON DILATATION CATHETER	Class IV
CA	92292	HIGH PRESSURE PERIPHERAL DILATION CATHETER	Class IV

Creagh Medical Ltd. Dba Surmodics, Inc.

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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