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OLEA MEDICAL SAS

France · La Ciotat

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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 1Class II 2Class III 0

plus 9 registration records and 14 510(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

2active device licences

Class II 2

12 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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 States9 registration records, 14 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: OLEA MEDICAL · OLEA MEDICAL SAS

FDA 510(k) clearances by year

22009

12011

12012

12013

12016

12021

12022

42023

22025

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243680	Neurovascular Insight V1.0	2025-08-25
US	K243681	Neuro Insight V1.0	2025-07-23
US	K223091	CT Perfusion V1.0	2023-06-09
BR	80102511483	SOFTWARE PARA ANÁLISE DE IMAGENS MÉDICAS	Class II
BR	80102519057	SOFTWARE PARA ANÁLISE DE IMAGENS MÉDICAS	Class II
BR	80102519058	SOFTWARE PARA ANÁLISE DE IMAGENS MÉDICAS	Class II
CA	82774	PERFSCAPE	Class II
CA	82775	NEUROSCAPE	Class II

OLEA MEDICAL SAS

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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