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CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.

China · Changzhou Jiangsu

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Singapore, Australia, Israel — 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

13listed device types

Class I 7Class II 6Class III 0

plus 13 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 2Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States13 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.

FDA 510(k) clearances by year

22022 · K221310

12023 · K232244

FDA listed device types

showing 8 of 13

Trap, Sterile Specimen 1Endoscope Introducer Kit 1Endoscopic Irrigation/Suction System 1Bottle, Collection, Vacuum 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1Endoscope Channel Accessory 1Accessories, Cleaning Brushes, For Endoscope 1Lubricant, Patient 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232244	Disposable Endoscope Valves System	2023-11-29
US	K221310	Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing	2022-10-07
US	K221331	Disposable Endoscope Valves System	2022-09-08

CHANGZHOU ENDOCLEAN MEDICAL DEVICE 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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