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Zhejiang Gongdong Medical Plastic Factory

China · Huangyan Taizhou Zhejiang

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

40listed device types

Class I 32Class II 7Class III 0unclassified 1

plus 42 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

30registered devices

Class I 30

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

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

United States42 registration records, 5 510(k), 0 PMA

Brazil30 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Zhejiang Gongdong Medical Technology Co., Ltd · ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD · ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO. LTD. · ZHEJIANG GONGDONG MEDICAL TECHNNOLOGY CO LTD · ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY · Zhejiang Gongdong Medical Technology Co,.Ltd.

FDA 510(k) clearances by year

12005 · K050887

12008 · K082042

12020 · K201523

12022 · K220739

12025 · K253222

FDA listed device types

showing 8 of 40

Forceps 1Container, Specimen, Sterile 1Device, Specimen Collection 1Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Dish, Tissue Culture 1Cassettes, Tissue 1Culture Media, Non-Selective And Non-Differential 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253222	Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)	2025-12-22
US	K220739	Disposable Urine Collection Tube	2022-11-17
US	K201523	Sharps container	2020-11-12
BR	10379860110	MICROTUBO PARA COLETA DE SANGUE	Class I
BR	10379860118	COLETOR DE URINA COM DISPOSITIVO DE TRANSFERÊNCIA	Class I
BR	10379860123	TUBO PARA COLETA DE URINA	Class I
SA	ME0000021567SFDAA00001	Verona	—

Zhejiang Gongdong Medical Plastic Factory

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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