Vuno, Inc.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Singapore — 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

3listed device types

Class I 0Class II 3Class III 0

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

4valid device licences

Class II 4

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States2 registration records, 2 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: VUNO INC.

FDA 510(k) clearances by year

12023 · K231398

12024 · K241439

FDA listed device types

Radiological Computer-Assisted Prioritization Software For Lesions 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241439	VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage	2024-11-15
US	K231398	VUNO Med-DeepBrain	2023-10-04
BR	82764710001	VUNO Med-Chest X-ray	Class II
BR	10302860285	Vuno Med - DeepBrain	Class II
BR	10302860286	Vuno Med - LungCT AI	Class II

Vuno, 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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