DxGen Corp.

Korea, Republic · Gyeonggi-do · www.dxgen.co.kr

✓ Record-verifiedregistrations found in 2 marketsEU SRN KR-MF-000030876

This company has registrations in European Union, Brazil — 2 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

5UDI-DI device records

IVD A 2IVD general 3

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

4registered devices

Class II 4

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

European Union5 raw hits, 0 excluded, 5 confirmed

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: DXGEN CORP.

Regulatory identity

EU manufacturer SRN: KR-MF-000030876
EU authorised representative: Medical Technology Promedt Consulting GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08800031900063	AUTODXTM Analyzer	IVD A
EU	08800031900094	AUTODXTM HbA1c Test	IVD general
EU	08800031900025	Epithod®616 Analyzer	IVD A
EU	08800031900353	AUTODXTM U-Albumin Test	IVD general
BR	10387650138	Kit para Teste HbA1c Epithod®	Class II
BR	10387650139	Kit para teste U-Albumin Epithod®	Class II
BR	10387650140	Epithod® 414 AutoDx	Class II

DxGen Corp.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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