BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    REGEN LAB Sa

    Reg #: 3008496303 · FEI: 3008496303 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    REGEN LAB Sa
    Registration Number
    3008496303
    FEI Number
    3008496303
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    EN BUDRON B2
    City
    LE MONT-SUR-LAUSANNE Vaud
    Country
    CH

    Regulatory Submissions

    510(k) Number
    BK090048

    Owner / Operator

    Firm Name
    RegenLab
    Operator Number
    10033110
    Address
    95 Greene St
    City
    Jersey City
    State
    NJ
    Postal Code
    07302
    Country
    US

    US Agent

    Business Name
    RegenLab USA
    Contact Name
    Giuseppe Calloni
    Address
    95 Greene St
    City
    Jersey City
    State
    NJ
    ZIP
    07302
    Country
    US
    Email
    [email protected]
    Phone
    332 9996604

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Peripheral Blood Processing Device For Wound Management PMQ
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Media And Components, Synthetic Cell And Tissue Culture KIT
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Bottle, Roller, Tissue Culture KJC

    Proprietary Names

    RegenKit - THT RegenKit®-Wound Gel-2 A-CP-Kit Family Kits CuteCell in vitro RegenKit-BCT Family Kits: Regen Spray Applicator Stryker Universal Centrifuge RegenET (ref: R-ET-3, R-ET-3 x 10) RegenKit-BCT-1 Plus RegenKit-BCT-2 Plus

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)