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Home›Korea, Republic›SEIN ELECTRONIC CO. LTD

SEIN ELECTRONIC CO. LTD

Korea, Republic · Anyang-City
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
12510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
3 including historic records
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 States0 registration records, 12 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: SEIN ELECTRONIC CO. LTD
Same-named companies — This database also contains companies with near-identical names: Sein Electronics Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Korea, Republic
City
Anyang-City

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

11991
21996
11999
32000
12001
32004
12005

Registration details (sample)

MarketIdentifierNameClass / date
USK052108SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-1002005-12-07
USK042138FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-3112004-08-24
USK042014DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-94002004-08-06

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