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Koios Medical, Inc.

USA · New York

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 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

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 4 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

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 States4 registration records, 4 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: Koios Medical, Inc. · KOIOS MEDICAL, INC.

FDA 510(k) clearances by year

12019 · K190442

12021 · K212616

12024 · K242130

12026 · K253884

FDA listed device types

System, Image Processing, Radiological 1Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer 1Automated Radiological Image Processing Software 1

Market	Identifier	Name	Class / date
US	K253884	Koios DS (3.8)	2026-07-02
US	K242130	Koios DS	2024-11-15
US	K212616	Koios DS	2021-12-16
BR	81464750108	Koios DS	Class II

Koios Medical, 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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