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JEIL MEDICAL CORPORATION

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 7 markets

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

60listed device types

Class I 40Class II 20Class III 0

plus 128 registration records and 53 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

33registered devices

Class I 13Class II 20

53 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

10 including historic records

TWTaiwanTFDA

14valid device licences

Class I 3Class II 11

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

18active ARTG entries

Class I 8IIa 2IIb 7Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 1Class 2a 1Class 2b 3Class 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 States128 registration records, 53 510(k), 0 PMA, 2 excluded

Brazil33 confirmed, 1 excluded

Manufacturer names merged into this page: JEIL MEDICAL CORPORATION

FDA 510(k) clearances by year

12004

12005

22009

12010

22011

12012

32013

22014

32015

42016

82017

22018

22019

32020

12021

22022

32023

32024

62025

12026

FDA listed device types

showing 8 of 60

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Implant, Endosseous, Orthodontic 1Screw, Fixation, Bone 1Implant, Endosseous, Root-Form 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252246	Leforte MMF System	2026-04-02
US	K252826	ARIX Femur Nail System	2025-12-10
US	K251431	FIX-C PEEK ACIF SA System	2025-06-27
BR	80991389053	Instrumentais para o Sistema de hastes para fêmur ARIX	Class II
BR	80991389054	Instrumentais para o Sistema de cotovelo ARIX	Class II
BR	82446229001	INSTRUMENTAIS JEIL NEURO E BUCOMAXILO	Class II

JEIL MEDICAL CORPORATION

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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