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FRANCE CHIRURGIE INSTRUMENTATION SAS (FCI S.A.S.)

France · Paris

✓ Record-verifiedregistrations found in 6 markets

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

31listed device types

Class I 15Class II 14Class III 0unclassified 2

plus 51 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

8 including historic records

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

30active device licences

Class II 22Class III 8

57 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 3IIa 8Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

Australia, Saudi Arabia, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States51 registration records, 8 510(k), 0 PMA, 3 excluded

Brazil6 confirmed, 1 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada30 confirmed, 0 excluded

Manufacturer names merged into this page: FCI FRANCE CHIRURGIE INSTRUMENTATION · FRANCE CHIRURGIE INSTRUMENTATION SAS (FCI S.A.S.) · FRANCE CHIRURGIE INSTRUMENTATION SAS (FCI S.A.S) · France Chirurgie Instrumentation SAS

FDA 510(k) clearances by year

22012 · K121142

12013 · K130375

12016 · K161373

12020 · K201606

22021 · K203569

12022 · K212741

FDA listed device types

showing 8 of 31

Weights, Eyelid, External 1Weights, Eyelid, Implantable 1Image, Illumination, Fiberoptic, For Endoscope 1Implant, Eye Sphere 1Conformer, Ophthalmic 1Laser, Ophthalmic 1Photocoagulator And Accessories 1Endoilluminator 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212741	EZYPOR	2022-06-24
US	K203569	Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants	2021-06-11
US	K201892	Ritleng®+ and Ritleng®+ PVP	2021-03-11
BR	80170289011	TROCARTE RETILOCK® NÃO VALVULADO	Class II
BR	80170289012	TROCARTE RETILOCK® VALVULADO	Class II
BR	10332030129	ADAPTADOR DE FIBRA ÓTICA PARA ZEISS VISALIS	Class I
CA	101819	FCI HORIZONTAL SCISSORS	Class II
CA	101820	FCI VERTICAL SCISSORS	Class II
CA	101847	FCI BRUSH TIP CANNULA	Class II

FRANCE CHIRURGIE INSTRUMENTATION SAS (FCI S.A.S.)

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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