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Home›SHENZHEN CAREWELL ELETRONICS CO. LTD

SHENZHEN CAREWELL ELETRONICS CO. LTD

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
2listed device types
Class I 0Class II 2Class III 0
plus 2 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class II 6
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
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 States2 registration records, 3 510(k), 0 PMA, 2 excluded
Brazil6 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN CAREWELL ELECTRONICS CO., LTD. · SHENZHEN CAREWELL ELECTRONICS CO. LTD · SHENZHEN CAREWELL ELETRONICS CO. LTD
Same-named companies — This database also contains companies with near-identical names: SHENZHEN CAREWELL ELECTRONICS CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

12012 · K113485
12018 · K180432
12020 · K200036

FDA listed device types

Computer, Diagnostic, Programmable 1Electrocardiograph 1

Registration details (sample)

MarketIdentifierNameClass / date
USK200036AI-ECG Tracker2020-03-20
USK180432AI-ECG Platform2018-11-19
USK113485ELECTROCARDIOGRAPH2012-04-25
BR80102519334Registrador HolterClass II
BR80901119019Eletrocardiografo Neo ECGClass II
BR80901119020EletrocardiografoClass II

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