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Leltek Inc.

Taiwan · New Taipei City · www.leltek.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN TW-MF-000013923

This company has registrations in European Union, United States, Brazil, Singapore, South Korea, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

33UDI-DI device records

Class IIa 33

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 3 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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.

European Union33 raw hits, 0 excluded, 33 confirmed

United States3 registration records, 5 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: Leltek Inc. · LELTEK INC.

Regulatory identity

EU manufacturer SRN: TW-MF-000013923
EU authorised representative: MedNet EC-REP GmbH

FDA 510(k) clearances by year

12020 · K191235

12021 · K210432

12022 · K222365

12024 · K241161

12025 · K243226

FDA listed device types

Stand, Infusion 1System, Imaging, Pulsed Doppler, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719882150050	Leltek	Class IIa
EU	04719882150067	Leltek	Class IIa
EU	04719882152092	ASUS	Class IIa
EU	04719882152085	ASUS	Class IIa
US	K243226	Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)	2025-05-08
US	K241161	Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging	2024-09-11
US	K222365	Leltek Ultrasound Imaging System (Model: LU700 Series)	2022-10-25
BR	80867159016	Familia Sistema de Imagem Ultrassom Leltek/ InnocareDR - Série 128	Class II
BR	80867150219	SOFTWARE DIGITALIZADOR DE IMAGENS DE ULTRASSOM LELTEK/ INNOCARE DR	Class II
BR	80867159017	Família de Sistema de Imagem Ultrassom Leltek / InnocareDR Série LX	Class II

Leltek Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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