HomeChinaGuangzhou Ekai Electronic Technology Co., Ltd.

Guangzhou Ekai Electronic Technology Co., Ltd.

China · Liwan District Guangzhou
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
54registered devices
Class I 9Class II 45
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 9
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States2 registration records, 1 510(k), 0 PMA
Brazil54 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD. · GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO., LTD. · GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO. LTD · Guangzhou Ekai Electronic Technology Co. Ltd · GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD

Company information

Country
China
City
Liwan District Guangzhou

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

12023 · K230420

FDA listed device types

Powered Microneedle Device 1

Registration details (sample)

MarketIdentifierNameClass / date
USK230420Dr. pen Microneedling System2023-08-11
BR82716119002CARTUCHOS DE AGULHAS DESCARTÁVEIS PARA MICROAGULHAMENTOClass II
BR82716119001CARTUCHOS DE AGULHAS NANO DESCARTÁVEIS PARA MICROAGULHAMENTOClass II
BR80988519011iStampClass II
SAME0000008788SFDAA00001DR PEN WIRED
SAME0000008788SFDAA00002DR PEN WIRELESS

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