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NEWMEDICAL TECHNOLOGY, INC.

USA · Northbrook

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, 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

2listed device types

Class I 1Class II 0Class III 0unclassified 1

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States3 registration records, 3 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: NEWMEDICAL TECHNOLOGY, INC. · NewMedical Technology, Inc.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K041704	NEWGEL AND NEWGEL PLUS E	2005-10-17
US	K040064	NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR	2004-03-23
US	K030485	NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR	2003-12-03
BR	80057050007	NEWGEL+ PLACA DE GEL DE SILICONE PARA TRATAMENTO DE CICATRIZES	Class II
BR	80057050009	NEWGEL+E GEL DE SILICONE AVANÇADO PARA CICATRIZES	Class II
SA	ME0000000527SFDAA00004	NewGel™+UV	—
SA	ME0000000527SFDAA00007	NewGel+E	—

NEWMEDICAL TECHNOLOGY, INC.

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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