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REGEN LAB Sa

Matched from indexed company URL: REGEN LAB SA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30084963033008496303REGEN LAB Sa1N2026-01-01EN BUDRON B2 LE MONT-SUR-LAUSANNE Vaud CH 1052

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1190971163020400K122122REGEN SPRAY APPLICATOR,FMF2012-11-09
1190971178928953BK120066
1190971029727989BK120057
1190971053063911BK110061
1190971983540782BK090048
1190971012423311
1190971765109681
1190971849072086
1190971955429822

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF12012-11-09

PMN#

GUDID#

RegenPlasma/RegenKit-Woud Gel-2 - The RegenKit®-Wound Gel-2 contains 2 RegenWound PRP Tubes and 1 RegenWound ATS Tube. INTENDED USE / INDICATIONS FOR USERegenKit®-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (RegenWound Gel) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the RegenWound Gel is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds.

REGEN LAB SA

2023-01-19