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Smartdata Suzhou Co., Ltd.

China · Suzhou Jiangsu

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Israel — 3 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

11listed device types

Class I 5Class II 6Class III 0

plus 20 registration records and 4 510(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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class Is (sterile) 2

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 States20 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: SMARTDATA SUZHOU CO., LTD

FDA 510(k) clearances by year

12018 · K181509

32019 · K191366

FDA listed device types

showing 8 of 11

Endoscopic Irrigation/Suction System 1Bottle, Collection And Trap, Breathing System (Uncalibrated) 1Bronchoscope Accessory 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1Endoscopic Storage Cover 1Endoscope Channel Accessory 1Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Pad, Eye 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191366	Vacutore Air/Water Bottle Tubing	2019-09-06
US	K191231	Andorate Auxiliary Water Connector, Andorate Valves Set	2019-06-07
US	K182998	Andorate Auxiliary Water Connector	2019-04-17

Smartdata Suzhou 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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