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Fiberoptics Technology, Inc.

USA · Pomfret CT · www.fiberopticstech.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN US-MF-000018020

This company has registrations in European Union, United States, United Kingdom, Australia — 4 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

3UDI-DI device records

Class I 3

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 6 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 3

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

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.

European Union18 raw hits, 15 excluded, 3 confirmed

United States6 registration records, 2 510(k), 0 PMA, 5 excluded

United Kingdom3 confirmed, 0 excluded

Manufacturer names merged into this page: FIBEROPTICS TECHNOLOGY, INC.

Regulatory identity

EU manufacturer SRN: US-MF-000018020
EU authorised representative: Wellkang Ltd
UK responsible person: Wellkang Ltd

FDA 510(k) clearances by year

11991 · K904378

12010 · K102167

FDA listed device types

Light Source, Fiberoptic, Routine 1Led Light Source 1Stimulator, Nerve 1Light, Surgical, Fiberoptic 1Headlight, Fiberoptic Focusing 1Source, Carrier, Fiberoptic Light 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-00862658000326HZ	HL	Class I
EU	D-00862658000319J4	MG	Class I
EU	D-00862658000302HK	LO	Class I
UK	35507	Medical Light Guide	Class I
UK	32241	Fiber Optic Light Source	Class I
UK	46808	Surgical Headlamp	Class I
US	K102167	LO-50 LED LIGHT SOURCE	2010-08-17
US	K904378	F.T.I. MEDICAL LIGHT GUIDE	1991-01-16

Fiberoptics Technology, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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