HomeChinaDONGGUAN KAISER TECHNOLOGY CO., LTD.

DONGGUAN KAISER TECHNOLOGY CO., LTD.

China · Dongguan City Guangdong
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Israel — 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
7listed device types
Class I 4Class II 3Class III 0
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 3Class II 1
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
5valid device licences
Class I 5
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
10active ARTG entries
Class I 1IIa 8Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
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 States7 registration records, 0 510(k), 0 PMA, 4 excluded
Brazil4 confirmed, 1 excluded
Manufacturer names merged into this page: DONGGUAN KAISER TECHNOLOGY CO., LTD · DONGGUAN KAISER TECHNOLOGY CO., LTD.

Company information

Country
China
City
Dongguan City Guangdong

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

Pack, Hot Or Cold, Water Circulating 1Light, Surgical, Instrument 1Lavage, Jet 1Tape And Bandage, Adhesive 1Saw, Powered, And Accessories 1Pack, Hot Or Cold, Reusable 1Mixer, Cement, For Clinical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81207910001Misturadores de cimento ósseo OsronClass I
BR81207910002Osron Surgical LedClass I
BR81362049001SISTEMA PULSE DE LAVAGEMClass II

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