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JPI Healthcare Co., Ltd.

Korea, Republic · Seoul · www.jpi-korea.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN KR-MF-000002016

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 9 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

4UDI-DI device records

Class I 2Class IIa 1Class IIb 1

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 6 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 1Class IIa 1Class IIb 1

BRBrazilANVISA

1registered devices

Class I 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

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 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.

European Union4 raw hits, 0 excluded, 4 confirmed

United States6 registration records, 11 510(k), 0 PMA, 2 excluded

United Kingdom3 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: JPI Healthcare Co., Ltd · JPI HEALTHCARE CO., LTD.

Regulatory identity

EU manufacturer SRN: KR-MF-000002016
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Business registration

KRX ticker code: 0010V0
Registration status: Active
Incorporated: 2025-08-21

Business registration data from KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11995

21996

12011

12012

12015

12016

12017

12022

12025

12026

FDA listed device types

System, Image Processing, Radiological 1System, X-Ray, Stationary 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Grid, Radiographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809413811188	—	Class IIb
EU	08809413810679	—	Class IIa
EU	08809413810204	Grid-1000	Class I
EU	08809413810211	Grid-2100	Class I
UK	40866	Digital Radiography X-ray System	Class IIa
UK	37645	Digital Radiography X-ray System	Class IIb
UK	40915	Stationary x-ray grid	Class I
US	K260482	DRE Duo	2026-06-15
US	K244010	ExamVue Apex	2025-02-24
US	K213057	ExamVue Duo	2022-02-18
BR	10410130032	GRADE ANTI-DIFUSORA LUMAX - JPI	Class I

JPI Healthcare Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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