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Henan Lusterdent Medical Instrument Co., Ltd

China · Zhengzhou Henan

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Australia, Hong Kong, Israel — 5 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

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 15Class II 0Class III 0

plus 15 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

28registered 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

3active ARTG entries

Class I 1IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 States15 registration records, 0 510(k), 0 PMA

Saudi Arabia28 confirmed, 0 excluded

Manufacturer names merged into this page: Henan Lusterdent Medical Instrument Co.,Ltd · Henan Lusterdent Medical Instrument Co., Ltd

FDA listed device types

showing 8 of 15

General Purpose Dental Tray 1Unit, Syringe, Air And/Or Water 1Spreader, Pulp Canal Filling Material, Endodontic 1Bur, Dental 1Instruments, Dental Hand 1Point, Paper, Endodontic 1Point, Abrasive 1File, Pulp Canal, Endodontic 1

Market	Identifier	Name	Class / date
SA	ME0000001698SFDAA00001	Endodontic Files	—
SA	ME0000001698SFDAA00001	Endodontic Files	—

Henan Lusterdent Medical Instrument Co., Ltd

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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