FDA.reportPublic FDA data

LEO MEDICAL CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113473003011347300LEO MEDICAL CO., LTD.1N2026-01-01No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Changzhou Jiangsu CN 213022

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3369311446233164K241888Single-use Balloon Dilatation CatheterFGE2024-12-20
3369311158773842K172985Ligation DeviceFHN2018-06-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGE12024-12-20
FHN12018-06-14

PMN#

GUDID#

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