FDA.reportPublic FDA data

KERECIS EHF

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30164292463016429246KERECIS EHF1N2026-01-01Sundstraeti 38 Isafjordur Vestfiroir IS 400

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2924891255655608K243843Tendon Protect (50242)OWY2025-06-04
2924891671447998K213231Kerecis SiliconeKGN2022-06-29
2924891424342713K202430Kerecis ReconstructOXH2021-05-02
2924891749320705K190528MariGen Wound ExtraKGN2019-07-10
2924891926044438K132343MARIGEN WOUND DRESSINGKGN2013-10-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGN32022-06-29
OWY12025-06-04
OXH12021-05-02