HomeKorea, RepublicVIOL Co., Ltd.

VIOL Co., Ltd.

Korea, Republic · Seongnam-Si
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
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
6valid device licences
Class II 6
SGSingaporeHSA SMDR
4device registrations
CLASS C 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
3active registrations
Class 2b 3
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, 5 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: VIOL CO., LTD.

Company information

Country
Korea, Republic
City
Seongnam-Si

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 · K172023
12018 · K180872
12020 · K200185
12022 · K213612
12024 · K240897

Registration details (sample)

MarketIdentifierNameClass / date
USK240897Cellinew2024-11-26
USK213612SYLFIRM X2022-06-23
USK200185SYLFIRM X2020-04-22

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