HomeKorea, RepublicBiocetec Co., Ltd.

Biocetec Co., Ltd.

Korea, Republic · Seoul
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Russia — 4 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
4510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class 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
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 1Class 2b 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 States0 registration records, 4 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: BIOCETEC CO., LTD.

Company information

Country
Korea, Republic
City
Seoul

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

12017 · K163467
12019 · K182193
12020 · K190871
12023 · K231635

Registration details (sample)

MarketIdentifierNameClass / date
USK231635A-Line Advanced2023-06-06
USK190871Bio-TackS Orthodontic Mini Implant2020-01-17
USK182193S-Line2019-01-22
BR81083629016Braquete Ortodôntico de CerâmicaClass II

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