IMEDICOM CO., LTD.

Korea, Republic · Gunpo-Si

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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

17listed device types

Class I 13Class II 4Class III 0

plus 21 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 5Class II 14

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

1 including historic records

TWTaiwanTFDA

7valid device licences

Class I 1Class II 6

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 2IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States21 registration records, 7 510(k), 0 PMA

Brazil19 confirmed, 0 excluded

Manufacturer names merged into this page: IMEDICOM CO., LTD. · IMEDICOM CO., LTD · IMEDICOM Co.,LTD

FDA 510(k) clearances by year

12014 · K133669

42016 · K153296

12018 · K173541

12019 · K182287

FDA listed device types

showing 8 of 17

Motor, Surgical Instrument, Ac-Powered 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Forceps, General & Plastic Surgery 1Motor, Surgical Instrument, Pneumatic Powered 1Spinal Channeling Instrument, Vertebroplasty 1Burr, Orthopedic 1Tamp 1Injector, Vertebroplasty (Does Not Contain Cement) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K182287	MEDINAUT Plus	2019-04-06
US	K173541	EPINAUT	2018-08-24
US	K153296	MEDINAUT Kyphoplasty System	2016-07-29
BR	80012459004	EZX BLADE	Class II
BR	80012450044	EZX Acetabular Cup Removal System	Class I
BR	80082919007	SISTEMA DE PERFURADOR E SERRA A BATERIA ZAGUAR	Class II

IMEDICOM 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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