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Lumitex Medical Devices, Inc.

USA · Strongsville

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

3listed device types

Class I 2Class II 1Class III 0

plus 4 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

8active ARTG entries

Class I 3IIa 5

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 States4 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil5 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Lumitex Medical Devices, Inc. · LUMITEX MEDICAL DEVICES, INC. · LUMITEX MEDICAL DEVICES, Inc.

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10247539028	Sistema ProView De Fibra Óptica Cirúrgica	Class II
BR	80444810096	ILUMINADOR CIRURGICO	Class I
BR	80444810100	Cabo de Luz Bifurcado Lateral	Class I
SA	ME0000001725SFDAA00039	BiliSoft Pad Covers	—

Lumitex Medical Devices, Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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