FDA.reportPublic FDA data

ShenB Co Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30102265753010226575ShenB Co Ltd1N2026-01-01SHENB Tower, 74, Achasan-ro, Seongdong-gu Seoul KR 04782

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1907601310688175K241535Vybe RF IIGEI2024-09-25
1907601164737962K232223PlaDuo SystemGEI2023-10-24
1907601563767709K193070VIVACE Electrosurgical DeviceGEI2021-04-26
1907601126233490K150409VIVACE Electrosurgical SystemOUH2016-01-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI32024-09-25
OUH12016-01-15

PMN#

GUDID#