SEEGENE INC.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 9Class II 5

48 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 8Class III 1

23 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

18device registrations

CLASS B 3CLASS C 14CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

IVD Class 1 2IVD Class 2 3IVD Class 3 11

HKHong KongMDACS

28valid listings

IVD B 6IVD C 22

ILIsraelAMAR

24registrations

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, 1 510(k), 0 PMA, 1 excluded

Brazil14 confirmed, 1 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: Seegene Inc. · SEEGENE INC. · SEEGENE INC., · SEEGENE, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142156	SEEGENE ANYPLEX II HSV-1/2 ASSAY	2015-02-13
BR	81597710017	STARMag 96 X 4 Universal Cartridge Kit	Class I
BR	81597710018	AIOS	Class I
BR	81597710019	Seegene STARlet	Class I
CA	78341	SEEPLEX RV12 ACE DETECTION	Class II
CA	78342	SEEPLEX RV5 ACE SCREENING	Class II
CA	80035	SEEPLEX RV7 DETECTION	Class II

SEEGENE INC.

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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