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SOPRO A COMPANY OF ACTEON GROUP

France · La Ciotat Cedex

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia — 6 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

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class II 9

20 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 States0 registration records, 4 510(k), 0 PMA, 3 excluded

Brazil3 confirmed, 3 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada9 confirmed, 1 excluded

Manufacturer names merged into this page: SOPRO A COMPANY OF ACTEON GROUP · SOPRO ACTEON GROUP · SOPRO S.A A COMPANY OF ACTEON GROUP · SOPRO A Company of ACTEON Group

Registration details (sample)

Market	Identifier	Name	Class / date
US	K153367	S698 Symbioz flow	2016-06-17
US	K142995	SOPIX	2015-08-17
US	K151053	PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner	2015-07-31
BR	10368410033	Sistema de vídeo endoscopia - câmera de vídeo	Class II
BR	10368410035	Sistema de vídeo endoscopia - insuflador de CO2	Class II
BR	80840260019	Câmera Intraoral	Class I
SA	ME0000006130SFDAA00001	DUO FULL HD – S195 SENSOR	—
CA	74524	SOPRO MEDICAL CAMERA	Class II
CA	74525	SOPRO MEDICAL CAMERA HEAD	Class II
CA	74526	SOPRO MEDICAL CAMERA OBJECTIVE	Class II

SOPRO A COMPANY OF ACTEON GROUP

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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