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SUNOPTIC TECHNOLOGIES, LLC

USA · Jacksonville

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 7 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

17listed device types

Class I 7Class II 10Class III 0

plus 17 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States17 registration records, 1 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Manufacturer names merged into this page: SUNOPTIC TECHNOLOGIES, LLC · SUNOPTIC TECHNOLOGIES LLC · Sunoptic Technologies, LLC

FDA 510(k) clearances by year

12010 · K093792

FDA listed device types

showing 8 of 17

Light, Surgical, Floor Standing 1Light Source, Photographic, Fiberoptic 1Lamp, Operating-Room 1Light, Surgical, Endoscopic 1Light Source, Fiberoptic, Routine 1Laparoscope, Gynecologic (And Accessories) 1Light, Surgical, Fiberoptic 1Image, Illumination, Fiberoptic, For Endoscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K093792	LED LIGHT SOURCE	2010-03-18
BR	80145901310	GUIA DE LUZ EM FIBRA ÓPTICA	Class II
BR	80145901087	CABO DE FIBRA OPTICA	Class II
SA	ME0000015099SFDAA00102	Sunoptic	—
SA	ME0000015099SFDAA00002	LED 9500 HEADLIGHT ASSEMBLY	—

SUNOPTIC TECHNOLOGIES, LLC

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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