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FLUOPTICS SAS

France · Grenoble Auvergne-Rhone-Alpes

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Taiwan, Singapore, South Korea, 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

5listed device types

Class I 3Class II 2Class III 0

plus 7 registration records and 4 510(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

0active device licences

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States7 registration records, 4 510(k), 0 PMA, 2 excluded

Manufacturer names merged into this page: FLUOPTICS SAS

FDA 510(k) clearances by year

12014 · K132475

12018 · DEN170092

12019 · K190891

12023 · K230898

FDA listed device types

Table And Attachments, Operating-Room 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1Holder, Camera, Surgical 1Parathyroid Autofluorescence Imaging Device 1Confocal Optical Imaging 1

Market	Identifier	Name	Class / date
US	K230898	FLUOBEAM® LX Red	2023-07-28
US	K190891	Fluobeam LX	2019-07-31
US	DEN170092	Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System	2018-11-02

FLUOPTICS 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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