GenBody Inc.

Korea, Republic · Cheonan-Si Chungchungnam-do Cheonan-si · www.genbody.co.kr

✓ Record-verifiedregistrations found in 5 marketsEU SRN KR-MF-000043626

This company has registrations in European Union, United States, Brazil, Israel, Russia — 5 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

9UDI-DI device records

IVD A 1IVD B 2IVD C 4IVD general 2

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 1Class III 0unclassified 1

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 1Class 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.

European Union9 raw hits, 0 excluded, 9 confirmed

United States2 registration records, 1 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: GENBODY INC.

Regulatory identity

EU manufacturer SRN: KR-MF-000043626
EU authorised representative: Medical Technology Promedt Consulting GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08800076700451	HelicoSign Dry	IVD general
EU	08800076701328	ConfiGlu G1 Glucose Control solution 3	IVD C
EU	08800076701106	ConfiGlu G1 Glucose Control solution 2	IVD C
EU	08800076700819	ConfiGlu G1 Blood Glucose Test Strip	IVD C
US	K251916	GenBody COVID-19 Ag Home Test	2026-03-13

GenBody Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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