SOPRO

France · La Ciotat Cedex Bouches-Du-Rhone

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Singapore, Australia, 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

16listed device types

Class I 5Class II 11Class III 0

plus 36 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

25active ARTG entries

Class I 18IIa 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States36 registration records, 25 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 5 excluded

Saudi Arabia8 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SOPRO

FDA 510(k) clearances by year

21997

31998

21999

32000

22001

22002

12003

32007

12008

12009

22010

12011

12013

12023

FDA listed device types

showing 8 of 16

Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Camera, Television, Endoscopic, Without Audio 1Unit, Operative Dental 1Unit, Operative Dental, Accessories 1Source, Carrier, Fiberoptic Light 1Light-Induced Fluorescence Caries Detector 1Plaque Disclosing Kit 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223470	C50	2023-12-14
US	K121685	SOPROCARE	2013-03-12
US	K103813	SOPRO 281	2011-03-22
SA	ME0000000758SFDAA00004	PENTAX Medical USB Camera	—
SA	ME0000000758SFDAA00003	PENTAX Medical LED Light Source	—

SOPRO

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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