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LEMAITRE VASCULAR, INC.

USA · Burlington

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, 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

20listed device types

Class I 2Class II 17Class III 1

plus 61 registration records and 35 510(k), 41 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

19active device licences

Class II 17Class IV 2

51 including historic records

TWTaiwanTFDA

13valid device licences

Class II 13

SGSingaporeHSA SMDR

17device registrations

CLASS B 7CLASS C 1CLASS D 9

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

19active ARTG entries

Class I 3Class III 8IIa 6IIb 1Class Is (sterile) 1

HKHong KongMDACS

13valid listings

Class II 6Class IV 7

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 3Class 3 3

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 States61 registration records, 35 510(k), 41 PMA

Brazil7 confirmed, 0 excluded

Canada19 confirmed, 0 excluded

Manufacturer names merged into this page: LEMAITRE VASCULAR, INC. · LeMaitre Vascular Inc. · LEMAITRE VASCULAR INC. · LEMAITRE VASCULAR, INC · LEMAITRE VASCULAR INC

Business registration

Legal name: LEMAITRE VASCULAR INC
CIK: 0001158895
Registration status: Active
Listing status: Listed (LMAT)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

62003

12004

12005

12007

12009

42010

32011

32012

52013

22014

12015

12016

22018

22019

12020

12022

FDA listed device types

showing 8 of 20

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Vessel Guard Or Cover, To Facilitate Revision Surgeries 1Catheter, Continuous Flush 1Dura Substitute 1Catheter, Flow Directed 1Prosthesis, Vascular Graft, Of 6mm And Greater Diameter 1Stripper, Vein, External 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212894	PhasTIPP	2022-03-31
US	K190882	XenoSure Biologic Patch	2020-02-13
US	K190267	EZE SIT Valvulotome	2019-10-30
BR	80202910104	Cateter de Embolectomia TufTex Over-the-Wire	Class II
BR	80202910105	Cateter de Embolectomia TufTex 5F Over-the-Wire	Class II
BR	80202910079	Cateter de Embolectomia TufTex	Class II
CA	2604	DISPOSABLE LEMAITRE VALVULOTOME	Class II
CA	2715	REUSABLE LEMAITRE VALVULOTOME	Class II
CA	2716	THE REUSABLE HALL VALVULOTOME	Class II