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Lakong Medical Device Company, Ltd.

USA · City Of Industry

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

39listed device types

Class I 32Class II 6Class III 0unclassified 1

plus 38 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 5

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

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

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 States38 registration records, 2 510(k), 0 PMA

Brazil5 confirmed, 1 excluded

Saudi Arabia10 confirmed, 2 excluded

Manufacturer names merged into this page: LAKONG MEDICAL DEVICES CO., LTD. · Lakong Medical Devices Co., Ltd. · Lakong Medical Devices Co., Ltd · LAKONG MEDICAL Devices Co.,Ltd. · LAKONG MEDICAL DEVICES CO., LTD · Lakong Medical Devices Co. Ltd.

Same-named companies — This database also contains companies with near-identical names: LAKONG MEDICAL DEVICES CO., LTD., T P C Lakong Medical Devices co.,Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12011 · K103498

12026 · K251544

FDA listed device types

showing 8 of 39

Indicator, Physical/Chemical Sterilization Process 1Wrap, Sterilization 1Respirator, Surgical 1Scaler, Ultrasonic 1Compressor, Air, Portable 1Continuous Measurement Thermometer 1Light, Fiber Optic, Dental 1Chair, Surgical, Non-Electrical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251544	Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)	2026-08-07
US	K103498	LAKONG ULTRASONIC SCALER	2011-03-31
BR	81326930001	TAÇA PARA PROFILAXIA TPC	Class I
BR	81326930002	MICROAPLICADOR WAKS	Class I
BR	81326930003	Pontas Aplicadoras Descartáveis Odontológicas	Class I
SA	ME0000017751SFDAA00003	TPC ProClean Extra Oral Suction System	—
SA	ME0000017751SFDAA00004	TPC Digital Amalgamator	—

Lakong Medical Device Company, 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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