ECOTRON Co., Ltd.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Israel, Russia — 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

9listed device types

Class I 3Class II 6Class III 0

plus 8 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States8 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: ECOTRON Co., Ltd.

FDA 510(k) clearances by year

12015 · K151038

12016 · K160279

12018 · K180473

12022 · K221233

FDA listed device types

showing 8 of 9

Generator, High-Voltage, X-Ray, Diagnostic 1System, X-Ray, Film Marking, Radiographic 1Tube Mount, X-Ray, Diagnostic 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1Table, Radiologic 1System, X-Ray, Mobile 1Interventional Fluoroscopic X-Ray System 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221233	DT-703	2022-06-27
US	K180473	ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR	2018-03-23
US	K160279	ANYVIEW-500R Fluoroscopic Mobile X-Ray System	2016-10-14

ECOTRON 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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