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BOSTON SCIENTIFIC DO BRASIL LTDA

✓ 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

224listed device types

Class I 36Class II 139Class III 47unclassified 2

plus 1,757 registration records and 730 510(k), 6,390 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

53registered devices

Class I 5Class II 48

331 including historic records

SASaudi ArabiaSFDA

20registered imported devices

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

CACanadaMDALL

312active device licences

Class II 140Class III 53Class IV 119

992 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 States1,757 registration records, 730 510(k), 6,390 PMA, 49 excluded

Brazil53 confirmed, 13 excluded

Saudi Arabia20 confirmed, 1 excluded

Canada312 confirmed, 16 excluded

Manufacturer names merged into this page: Boston Scientific Corporation · Boston Scientific Limited · BOSTON SCIENTIFIC CORPORATION · BOSTON SCIENTIFIC DO BRASIL LTDA · BOSTON SCIENTIFIC LIMITED

Same-named companies — This database also contains companies with near-identical names: Boston Scientific /International Technologies, Boston Scientific/Medi-Tech, Boston Scientific - Precision Vascular. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

92007

122008

152009

132010

262011

282012

212013

342014

262015

162016

252017

172018

182019

192020

182021

162022

262023

142024

162025

122026

FDA listed device types

showing 8 of 224

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Catheter, Intracardiac Mapping, High-Density Array 1Lithotriptor, Biliary Mechanical 1Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling 1Probe, Radiofrequency Lesion 1Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262406	EluPro Antibiotic-Eluting BioEnvelope	2026-08-12
US	K262165	FARADRIVE Steerable Sheath (M004PF21M402)	2026-07-24
US	K262462	TheraSphere 360 Y-90 Management Platform	2026-07-24
BR	10341350268	CONJUNTO DILATADOR RENAL GRADUADO TIPO AMPLATZ	Class II
BR	10341350478	SMALL CUTTING BALLOON PERIFERICO	Class II
BR	10341350805	Percuflex Plus - Stent Ureteral	Class II
SA	ME0000000637SFDAA00022	Seal	—
SA	ME0000000537SFDAA00559	Blox™	—
CA	4538	ROLLERBALL	Class II
CA	4613	CARSON ZERO TIP URETRAL BALLON DILATION CATHETER KIT WITH HYDROPLUS COATING AND GLIDEWIRE	Class II
CA	5237	CRE WIRE-GUIDED BALLOON DILATATION CATHETER	Class II

BOSTON SCIENTIFIC DO BRASIL LTDA

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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