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BALT USA, LLC

USA · Irvine

✓ 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

10listed device types

Class I 0Class II 9Class III 1

plus 22 registration records and 20 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

8active ARTG entries

Class III 5IIa 2IIb 1

HKHong KongMDACS

3valid listings

Class II 1Class IV 2

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 1Class 3 2

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 States22 registration records, 20 510(k), 1 PMA, 1 excluded

Brazil0 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BALT USA, LLC · BALT USA · BALT USA LLC

FDA 510(k) clearances by year

22018

22019

12020

12021

22022

12023

42024

42025

32026

FDA listed device types

showing 8 of 10

Catheter, Continuous Flush 1Guide, Wire, Catheter, Neurovasculature 1Wire, Guide, Catheter 1Catheter, Thrombus Retriever 1Catheter, Percutaneous, Neurovasculature 1Device, Neurovascular Embolization 1Catheter, Intravascular Occluding, Temporary 1Device, Vascular, For Promoting Embolization 1

Market	Identifier	Name	Class / date
US	K260199	SLIM Microcatheter	2026-07-13
US	K254223	Next Generation 088 Catheter	2026-04-16
US	K254221	Optima Coil System (OptiOne Coil System)	2026-01-27

BALT USA, LLC

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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