FDA.reportPublic FDA data

ACE MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051267043005126704ACE MEDICAL1N2026-01-0133, NAEYOO-ROAD 124 DEOGYANG-GU GOYANG-SI Gyeonggi KR 10264
30190129293019012929ACE MEDICAL INDUSTRy CO., LTD.1N2026-01-0157-14 , Gwangjeok ro 228beon gil, Gwang jeok myeon Yangju-si Gyeonggi KR 11414
30118999943011899994ACE MEDICAL COMPANY1Y2020-04-252230 Park Ave, Suite 202 Cincinnati OH US 45206

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2925432047471230K242741ACE CannulaFMI2025-01-08
2925431458356807K200017Eclipse DermaFlex CannulaFMI2020-11-05
239791788993022K060258AUTOFUSERMEB2006-05-30
2925431027012758
239791581583170
2925431672365014

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI22025-01-08
MEB12006-05-30

PMN#

GUDID#

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