HomeThailandKAWASUMI LABORATORIES ( THAILAND ) CO. , LTD

KAWASUMI LABORATORIES ( THAILAND ) CO. , LTD

Thailand · Chok Chai Nakhon Ratchasima
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
10listed device types
Class I 0Class II 10Class III 0
plus 16 registration records and 29 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
2active device licences
Class II 2
10 including historic records
TWTaiwanTFDA
8valid device licences
Class II 7Class III 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States16 registration records, 29 510(k), 0 PMA, 3 excluded
Brazil2 confirmed, 1 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: KAWASUMI LABORATORIES (THAILAND) CO., LTD. · KAWASUMI LABORATORIES INC. · KAWASUMI LABORATORIES ( THAILAND ) CO. , LTD

Company information

Country
Thailand
City
Chok Chai Nakhon Ratchasima

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

21987
11989
51990
41993
31994
11997
11998
12000
12002
12003
22006
12008
22010
12013
12018
22019

FDA listed device types

showing 8 of 10
Needle, Fistula 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Set, I.V. Fluid Transfer 1Pump, Infusion 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Set, Transfer (Blood/Plasma) 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
USK190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)2019-07-08
USK190233K-Shield Advantage Port Access Infusion Set (PAIS)2019-05-02
USK172957Kawasumi Laboratories Blood Drawing Kit (BDK) System2018-09-28
BR10234400059AGULHA PARA ACESSO A CATETER TOTALMENTE IMPLANTAVEL TIPO HUBBERClass II
BR80464470001AGULHA DE FÍSTULAClass II
CA66629BLOOD DRAWING KITClass II
CA66635PHLEBOTOMY SETClass II

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