HomeKorea, RepublicShenB Co., Ltd.

ShenB Co., Ltd.

Korea, Republic · Seoul
✓ 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
3listed device types
Class I 0Class II 3Class III 0
plus 7 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 2Class 2b 2
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 States7 registration records, 11 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: ShenB Co Ltd · SHENB 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

12020
32021
12022
22023
12024
22025
12026

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Stimulator, Transcutaneous Electrical, Aesthetic Purposes 1Massager, Vacuum, Radio Frequency Induced Heat 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253926Diacore2026-04-10
USK251649Sunny Plus (Sunny)2025-09-18
USK242241Sunny2025-03-19
BR80380269021SISTEMA DE TRATAMENTO DE PELE VIVACEClass II

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