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Irvine Biomedical, Inc., A St. Jude Medical Company

USA · Irvine

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

9listed device types

Class I 0Class II 7Class III 2

plus 29 registration records and 13 510(k), 106 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

11active device licences

Class II 7Class III 2Class IV 2

23 including historic records

TWTaiwanTFDA

3valid device licences

Class II 1Class III 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

16active ARTG entries

Class I 2Class III 12IIa 1Class Is (sterile) 1

HKHong KongMDACS

4valid listings

Class II 1Class IV 3

ILIsraelAMAR

1registrations

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 States29 registration records, 13 510(k), 106 PMA, 9 excluded

Brazil0 confirmed, 6 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: IRVINE BIOMEDICAL. INC. · IRVINE BIOMEDICAL, INC. A ST. JUDE MEDICAL COMPANY · IRVINE BIOMEDICAL, INC. · Irvine Biomedical, Inc. A St. Jude Medical Company · Irvine Biomedical Inc a St Jude Medical Company

FDA 510(k) clearances by year

11995

11997

11998

31999

12001

12004

22006

12008

12014

12022

FDA listed device types

showing 8 of 9

Cable, Electrode 1Reprocessed Intravascular Ultrasound Catheter 1Catheter, Intracardiac Mapping, High-Density Array 1Catheter, Electrode Recording, Or Probe, Electrode Recording 1Computer, Diagnostic, Programmable 1Catheter, Ultrasound, Intravascular 1Introducer, Catheter 1Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223077	ViewFlex Xtra ICE Catheter	2022-12-07
US	K133853	VIEWFLEX XTRA ICE CATHETER	2014-05-19
US	K082061	INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER	2008-08-19
SA	ME0000001363SFDAA00001	Cardioversion Switchbox	—
SA	ME0000001363SFDAA00002	Cardioverter Cable	—
CA	68779	IBI-1500T6 CARDIAC (RF) ABLATION GENERATOR SYSTEM	Class III
CA	68863	CARDIAC ABLATION POSITIONING AND SIZING PACKS	Class II
CA	72818	CARDIOVERSION SWITCH BOX	Class II

Irvine Biomedical, Inc., A St. Jude Medical Company

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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