BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    GeTraP

    Reg #: 3009166014 · FEI: 3009166014 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KEDRION S.P.A.
    Registration Number
    3009166014
    FEI Number
    3009166014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Loc. Ai Conti
    City
    Barga (Castelvecchio Pascoli) Lucca
    Country
    IT

    Regulatory Submissions

    510(k) Number
    BK200456

    Owner / Operator

    Firm Name
    Kedrion Biopharma Inc.
    Operator Number
    10071674
    Address
    Parker Plaza, 400 Kelby Street, 11th Floor
    City
    Fort Lee
    State
    NJ
    Postal Code
    07024
    Country
    US
    Correspondent
    Nayana Lahoti

    US Agent

    Business Name
    Kedrion Biopharma Inc.
    Contact Name
    Nayana Lahoti
    Address
    Parker Plaza, 400 Kelby Street, 11th floor
    City
    Fort Lee
    State
    NJ
    ZIP
    07024
    Country
    US
    Email
    [email protected]
    Phone
    201 5828141

    Products

    Device Name Product Code
    Blood Establishment Computer Software And Accessories MMH

    Proprietary Names

    GeTraP

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198