BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    VOLISTA STANDOP

    Reg #: 3031563141 · FEI: 3031563141 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GETINGE AB
    Registration Number
    3031563141
    FEI Number
    3031563141
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KOPANINA 30A
    City
    POZNAN Wielkopolskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K130513

    Owner / Operator

    Firm Name
    Getinge AB
    Operator Number
    10090886
    Address
    Kopanina 30A
    City
    Poznan
    State
    Wielkopolskie
    Postal Code
    PL 60-105
    Country
    PL

    Products

    Device Name Product Code
    Light, Surgical, Ceiling Mounted FSY
    Lamp, Surgical FTD

    Proprietary Names

    VOLISTA STANDOP VOLISTA ACCESS VOLISTA VOLISTA STANDOP II VOLISTA ACCESS II

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198