HomeChinaAOJ HEALTH TECHNOLOGY CO., LTD.

AOJ HEALTH TECHNOLOGY CO., LTD.

China · Shenzhen
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, South Korea, 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
9listed device types
Class I 6Class II 3Class III 0
plus 9 registration records and 1 510(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
0active device licences
12 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
IIa 8
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States9 registration records, 1 510(k), 0 PMA, 2 excluded
Brazil2 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: AOJ HEALTH TECHNOLOGY CO., LTD. · AOJ HEALTH TECHNOLOGY CO., LTD

Company information

Country
China
City
Shenzhen

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

12024 · K233913

FDA listed device types

showing 8 of 9
Pump, Breast, Non-Powered 1Irrigator, Powered Nasal 1Catheters, Suction, Tracheobronchial 1Otoscope 1Cleaner, Denture, Mechanical 1Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1Pump, Breast, Powered 1Pad, Heating, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233913Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)2024-05-14
BR10332179014Bomba Tira Leite ElétricaClass II
BR10332179013Bomba Tira Leite ManualClass II

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