HomeChinaENDOCLOT PLUS CO., LTD.

ENDOCLOT PLUS CO., LTD.

China · Suzhou
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 1Class II 4Class III 0
plus 5 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
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1Class III 1IIa 2IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States5 registration records, 3 510(k), 0 PMA
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: ENDOCLOT PLUS CO., LTD. · EndoClot Plus Co., Ltd.

Company information

Country
China
City
Suzhou

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12017 · K162197
12020 · K191254
12021 · K190677

FDA listed device types

Compressor, Air, Portable 1Hemostatic Device For Endoscopic Gastrointestinal Use 1Laparoscope, General & Plastic Surgery 1Submucosal Injection Agent 1Tubing, Pressure And Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK190677EndoClot2021-01-29
USK191254EndoClot2020-01-30
USK162197EndoClot2017-01-18
SAME0000016372SFDAA00001Endoclot Air Compressor

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