HomeKorea, RepublicGenolution Inc.

Genolution Inc.

Korea, Republic · Incheon · www.genolution.co.kr
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 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
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
7registered devices
Class I 7
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
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 States1 registration records, 0 510(k), 0 PMA
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: Genolution Inc · GENOLUTION INC. · GENOLUTION

Company information

Country
Korea, Republic
City
Incheon
Website
www.genolution.co.kr
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

KRX ticker code
225220
Registration status
Active
Incorporated
2020-07-24

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

FDA listed device types

Clinical Sample Concentrator 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10355870342NextractorClass I
BR10355870352Reagente de extração de Ácido Nucleico Kit NA Viral NX-48Class I
BR10355870349Reagente de extração de Ácido Nucleico Kit DNA Sangue Total NX-48Class I

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