Claripi, Inc.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Singapore, Australia — 4 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

4listed device types

Class I 1Class II 3Class III 0

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

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.

United States5 registration records, 4 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: CLARIPI INC.

FDA 510(k) clearances by year

12019 · K183460

22021 · K203785

12022 · K203783

FDA listed device types

System, X-Ray, Tomography, Computed 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Digital Image Communications, Radiological 1

Market	Identifier	Name	Class / date
US	K203783	ClariPulmo	2022-04-06
US	K203785	ClariSIGMAM	2021-09-10
US	K212074	ClariCT.AI	2021-07-27
BR	82507970024	ClariPulmo	Class II
BR	82507970025	ClariCT.AI	Class II

Claripi, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies