BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Getinge IC Production Poland sp. z o.o.

    Reg #: 3012068831 · FEI: 3012068831 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Getinge IC Production Poland sp. z o.o.
    Registration Number
    3012068831
    FEI Number
    3012068831
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Szkolna 30
    City
    Plewiska Wielkopolskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K120441

    Owner / Operator

    Firm Name
    Getinge
    Operator Number
    9057664
    Address
    Ljungadalsgatan 11
    City
    VAXJO
    State
    Kronoberg
    Postal Code
    352 46
    Country
    SE

    Products

    Device Name Product Code
    Sterilizer, Steam FLE
    Cleaner, Ultrasonic, Medical Instrument FLG

    Proprietary Names

    GSS610N21 Series Steam Sterilizer Model 733HC-E Getinge 400HC-E/500HC-E Series Steam Sterilizer GSS67N Steam Sterilizer GSS610N10; GSS610N14, and GSS610N15 Steam Sterilizers Model 1150 - Lumen tray only Ultrasonic Cleaning System - Triton 36 Triton series - Lumen tray only Model 1101 RACS tray with S and SI adapters Model 1101 - Lumen Tray only Ultrasonic Cleaning System - Model 1522 Triton series - Lumen tray with an accessory kit SP Tray with adapters - Model 1101 Triton RACS tray S and Si with adapters Triton RACS Tray X and Xi with adapters Ultrasonic Cleaning System - Model 1100 Triton RACS Xi Tray - Tray only Ultrasonic Cleaning System - Model 1150 Ultrasonic Cleaning System - Model 1101 Model 1150 - Lumen tray with Accessory kit Triton RACS tray Xi with SP Adapters Xi RACS tray with adapters for Model 1101 Hospital wire mesh tray Getinge Aquadis PCU Model 1100 - Lumen tray only Model 1101 - Lumen Tray with Accessory kit Model 1100 - Lumen Tray with Accessory Kit Ultrasonic Cleaning System -Triton 72

    Establishment Types

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