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Eos Imaging, Inc.

France · Paris

✓ Record-verifiedregistrations found in 8 markets

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

4listed device types

Class I 1Class II 3Class III 0

plus 6 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

2active device licences

Class II 2

5 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 3IIb 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 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.

United States6 registration records, 17 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 2 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: EOS imaging · EOS IMAGING

FDA 510(k) clearances by year

22012

22013

12014

22015

12016

12018

12019

12020

12023

32024

22025

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, X-Ray, Stationary 1Chair, With Casters 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251078	AutoDensity	2025-11-14
US	K251747	VEA Align; spineEOS	2025-08-15
US	K233920	EOSedge	2024-08-06
CA	95224	LOGICIEL DE LA PLANIFICATION DE LA HANCHE - MODULE HIPEOS	Class II
CA	97584	SPINEEOS	Class II

Eos Imaging, 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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