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Zhuhai Pusen Medical Technology Co., Ltd.

China · Zhuhai

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

7listed device types

Class I 1Class II 6Class III 0

plus 8 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class II 12

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

8 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 4

HKHong KongMDACS

8valid listings

Class II 8

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States8 registration records, 7 510(k), 0 PMA, 1 excluded

Brazil12 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: Zhuhai Pusen Medical Technology Co., Ltd. · ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD. · Zhuhai Pusen Medical Technology Co.,Ltd

FDA 510(k) clearances by year

22017 · K172098

12019 · K190648

12022 · K222602

12023 · K223741

12024 · K233778

12026 · K260521

FDA listed device types

Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Access Overtube, Gastroenterology-Urology 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Choledochoscope And Accessories, Flexible/Rigid 1Ureteroscope And Accessories, Flexible/Rigid 1Laryngoscope, Rigid 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260521	ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)	2026-04-06
US	K233778	Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)	2024-07-16
US	K223741	Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)	2023-06-22
BR	83210069009	Pinça de preensão de uso único	Class II
BR	83210069010	Pinça de biópsia descartável	Class II
BR	83210069012	Fio-guia para Trato Urinário de Uso Único	Class II
SA	ME0000009017SFDAA00003	HD Medical Video Endoscope Image Processor	—
SA	ME0000009017SFDAA00002	Medical Video Endoscope Image Processor	—

Zhuhai Pusen Medical Technology Co., Ltd.

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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