Mediclus Co., Ltd.

Korea, Republic · Cheongju-Si Chungbuk

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia, Israel, Russia — 6 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

15listed device types

Class I 8Class II 6Class III 0unclassified 1

plus 22 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

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.

United States22 registration records, 15 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: MEDICLUS CO., LTD

FDA 510(k) clearances by year

12023

22024

62025 · K252465

62026 · K254201

FDA listed device types

showing 8 of 15

Sealant, Pit And Fissure, And Conditioner 1Liner, Cavity, Calcium Hydroxide 1Varnish, Cavity 1Material, Tooth Shade, Resin 1Resin, Root Canal Filling 1Agent, Tooth Bonding, Resin 1Cord, Retraction 1Wax, Dental, Intraoral 1

Market	Identifier	Name	Class / date
US	K254201	Any-Cem	2026-08-13
US	K261728	One-Fil LC	2026-07-21
US	K260485	Any-Etch	2026-05-14
SA	ME0000006649SFDAA00018	Any-Flex	—

Mediclus Co., 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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