BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Plenity®

    Reg #: 3012121187 · FEI: 3012121187 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GELESIS SRL
    Registration Number
    3012121187
    FEI Number
    3012121187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Europa, 187
    City
    Calimera Lecce
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K230133

    Owner / Operator

    Firm Name
    Gelesis srl
    Operator Number
    10060654
    Address
    Via Europa, 187
    City
    Calimera (LE)
    State
    Lecce
    Postal Code
    73021
    Country
    IT
    Correspondent
    Cosimo Saponaro

    US Agent

    Business Name
    THEMA CORP
    Contact Name
    Silvia Tamarri
    Address
    2929 Arch St
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US
    Email
    [email protected]
    Phone
    215 8459459

    Products

    Device Name Product Code
    Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss QFQ

    Proprietary Names

    Plenity®

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198