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ABBOTT LABORATORIES VASCULAR ENTERPRISES LTD.

Switzerland · Beringen

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

235listed device types

Class I 58Class II 158Class III 14unclassified 5

plus 715 registration records and 953 510(k), 1,632 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

55registered devices

Class I 29Class II 26

68 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

59active device licences

Class II 19Class III 4Class IV 36

130 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 States715 registration records, 953 510(k), 1,632 PMA, 57 excluded

Brazil55 confirmed, 28 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada59 confirmed, 24 excluded

Manufacturer names merged into this page: ABBOTT LABORATORIES · ABBOTT VASCULAR · Abbott Vascular Netherlands · Abbott Vascular · ABBOTT LABORATORIES, ABBOTT VASCULAR INC. · ABBOTT IRELAND VASCULAR DIVISION

FDA 510(k) clearances by year

42007

112008

112009

72010

152011

122012

52013

42014

112015

32016

82017

42018

32019

22020

12021

52022

72023

12024

32025

12026

FDA listed device types

showing 8 of 235

Counter, Differential Cell 1Igm, Antigen, Antiserum, Control 1Turbidimetric, Total Protein 1Enzyme Immunoassay, Benzodiazepine 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Catheter, Percutaneous 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Calibrator For Hemoglobin And Hematocrit Measurement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252424	Anti-HCV Next	2026-04-28
US	K243500	ARCHITECT iGentamicin	2025-07-09
US	K243168	Alinity i Rubella IgG	2025-06-20
BR	10055310785	WBC REAGENT PART B	Class I
BR	10055310787	WBC REAGENT PART A	Class I
BR	10055311064	ARCHITECT TSH CALIBRATORS / ARCHITECT TSH CALIBRATORES	Class II
CA	68139	SUTURE TRIMMERS	Class IV
CA	11181	KNOT PUSHER	Class II
CA	14494	HEARTFLO ANASTOMOSIS DEVICE (MECHANICALLY DRIVEN)	Class IV

ABBOTT LABORATORIES VASCULAR ENTERPRISES LTD.

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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