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Winner Industries (Shenzhen) Co., Ltd.

USA · Pomona

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Russia — 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 7Class II 1

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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 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 States0 registration records, 2 510(k), 0 PMA, 10 excluded

Brazil8 confirmed, 7 excluded

Saudi Arabia0 confirmed, 1 excluded

Manufacturer names merged into this page: WINNER INDUSTRIES (SHENZHEN) CO.,LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K062704	STERILIZATION POUCH WITH INDICATORS	2007-06-08
US	K023755	WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD	2003-06-10
BR	10330669082	COMPRESSA DE GAZE ESTÉRIL DESCARPACK IV	Class I
BR	10330669083	COMPRESSA PARA CAMPO OPERATÓRIO ESTÉRIL COM FILAMENTO RADIOPACO DESCAR	Class II
BR	80251280019	COMPRESSA DE GAZE NÃO ESTÉRIL SKY	Class I

Winner Industries (Shenzhen) Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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