Ewoosoft Co., Ltd.

Korea, Republic · Hwaseong-Si Gyeonggi

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 4 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

2listed device types

Class I 0Class II 2Class III 0

plus 32 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

2active device licences

Class II 2

14 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 3 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 States32 registration records, 31 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Ewoosoft Co., Ltd · EWOO SOFT CO., LTD. · EWOOSOFT CO., LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250005	Clever One	2025-05-23
US	K241114	EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)	2024-07-23
US	K231757	Ez3D-i /E3	2023-07-14
BR	80900480017	Clever RC	Class II
CA	92790	EZ3D-I (E3) DENTAL IMAGING SOFTWARE	Class II
CA	92791	EZDENT-I (E2, PRORAVIEW) DENTAL IMAGING SOFTWARE	Class II

Ewoosoft 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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