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ABBOTT IRELAND VASCULAR DIVISION

Ireland · Mervue

✓ Record-verifiedregistrations found in 4 markets

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

111listed device types

Class I 35Class II 70Class III 3unclassified 3

plus 171 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

168registered devices

Class I 26Class II 142

246 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

10active device licences

Class II 6Class IV 4

123 including historic records

TWTaiwanTFDA

0valid device licences

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 States171 registration records, 12 510(k), 0 PMA, 50 excluded

Brazil168 confirmed, 21 excluded

Saudi Arabia1 confirmed, 11 excluded

Canada10 confirmed, 16 excluded

Manufacturer names merged into this page: ABBOTT IRELAND · ABBOTT IRELAND DIAGNOSTICS DIVISION · STRYKER IRELAND LTD., INSTRUMENTS DIVISION · Stryker Ireland Ltd. Instruments Division, Innovation Centre · ABBOTT IRELAND VASCULAR DIVISION · ABBOTT IRELAND, DIAGNOSTICS DIVISION

Same-named companies — This database also contains companies with near-identical names: ABBOTT IRELAND DIAGNOSTIC DIVISION, ABBOTT IRELAND - DIAGNOSTICS DIVISION. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22008

12021

62022 · K223324

12023 · K223317

22025 · K252357

FDA listed device types

showing 8 of 111

Electrosurgical, Cutting & Coagulation & Accessories 1Sirolimus Test System 1Igm, Antigen, Antiserum, Control 1Thoracolumbosacral Pedicle Screw System 1Alkaline Picrate, Colorimetry, Creatinine 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Calibrator, Secondary 1Bromcresol Purple Dye-Binding, Albumin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252357	Glucose2	2025-10-24
US	K244042	Calcium2	2025-02-10
US	K223317	Alkaline Phosphatase2	2023-07-21
BR	10055310998	ARCHITECT PROLACTIN REAGENTS	Class II
BR	10055311012	ARCHITECT PROGESTERONE REAGENTS	Class II
BR	80146502246	Alinity i Cyclosporine Whole Blood Precipitation Reagent Kit	Class I
SA	ME0000002989SFDAA00176	flexitainer	—
CA	687	BIODIVYSIO DIVYSIO PC STENT (UNMOUNTED STENT)	Class IV
CA	71894	EMBOSHIELD RAPID EXCHANGE & EMBOLIC PROTECTION SYSTEM	Class IV
CA	688	BIODIVYSIO CORONARY STENT SYSTEM	Class IV

ABBOTT IRELAND VASCULAR DIVISION

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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