HomeThailandJenius Medical Sci-Tech (Thailand) Co., Ltd.

Jenius Medical Sci-Tech (Thailand) Co., Ltd.

Thailand · Nong Yai District Chon Buri
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
29listed device types
Class I 28Class II 1Class III 0
plus 56 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 4
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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 States56 registration records, 0 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: NINGBO JENIUS POLYMER SCI-TECH CO., LTD · Jenius Medical Sci-Tech (Thailand) Co., Ltd. · NINGBO JENIUS POLYMER SCI-TECH CO.,LTD · Ningbo Jenius Polymer Sci-Tech Co.,LTD

Company information

Country
Thailand
City
Nong Yai District Chon Buri

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 listed device types

showing 8 of 29
Pad, Eye 1Forceps 1Exerciser, Non-Measuring For Stroke Rehabilitation 1First Aid Kit Without Drug 1Bedding, Disposable, Medical 1Dressing, Wound, Occlusive 1Solution, Isotonic 1Exerciser, Non-Measuring 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80540440013GARROTE DESCARTÁVELClass I
BR81535970005GARROTE DESCARTÁVELClass I
BR10379860283GARROTE DESCARTAVEL PARA FLEBOTOMIAClass I
SAME0000004283SFDAA00002Jenius

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