BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    GETINGE AB

    Reg #: 3031563141 · FEI: 3031563141 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    77
    Establishment Types
    1
    Classifications
    23

    Registration Details

    Registration Name
    GETINGE AB
    Registration Number
    3031563141
    FEI Number
    3031563141
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KOPANINA 30A
    City
    POZNAN Wielkopolskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K122625

    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
    Sterilizer, Steam FLE
    Holder, Head, Radiographic IWY
    Stretcher, Wheeled FPO
    Table, Operating-Room, Ac-Powered FQO
    Table, Operating-Room, Manual FSE
    Light, Surgical, Ceiling Mounted FSY
    Light, Surgical, Floor Standing FSS
    Cleaner, Ultrasonic, Medical Instrument FLG
    Surgical Table Cushion LWG
    Light, Surgical, Accessories FTA
    Lamp, Surgical FTD
    Table, Radiographic, Stationary Top IXQ
    Hook, Bone KIK
    Holder, Camera, Surgical FXR
    Table, Radiologic KXJ
    Table And Attachments, Operating-Room BWN
    Table, Surgical With Orthopedic Accessories, Ac-Powered JEA
    Headrest, Neurosurgical HBM
    Camera, Surgical And Accessories KQM
    Warmer, Irrigation Solution LHC
    Device, Medical Examination, Ac Powered KZF
    Disinfector, Medical Devices MEC
    Led Light Source NTN

    Proprietary Names

    Getinge 800HC-E Series Steam Sterilizer 1180 52A0 Multimodality Headrest, Fixed Rigid Head Rest 1002.82A0 Transmobile TT, Transmobile TT-M ALPHACLASSIC MAGNUS ALPHAMAQUET OTESUS ALPHASTAR ALPHAMAXX MAQUET OPERATING TABLES CORIN ORTHOSTAR BETASTAR YUNO II MEERA, MEERA ST, MEERA CL YUNO ALPHASTAR PRO BETACLASSIC X'TEN (X10) Hanaulux Blue 80 Hosp Model 733HC-E Getinge Aquadis PCU Hanaulux Blue 30 80 Gel pads MAQUET STERIGRIP PowerLED 500 Rolite Power LED POWERLED PowerLED 300 PowerLED 700 Model 633 AXCEL VOLISTA STANDOP II VOLISTA ACCESS VOLISTA ACCESS II VOLISTA STANDOP VOLISTA 1180.12F0 Multimodality Transfer Table Top 1180.71C0 Transfer Board Getinge 400HC-E/500HC-E Series Steam Sterilizer YUNO Femur Hook MAQUET EQUIPMENT SATELITE MEDIA HD GSS610N21 Series Steam Sterilizer GSS67N Steam Sterilizer MAQUET MAGNUS carbon-fibre table top (1180.16XX; T285.7000) TRIMANO Fortis TRIMANO Accessories to YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA Maquet Rolite Maquet PowerLED II Maquet EZEA GSS610N10; GSS61014, and GSS61015 Steam Sterilizers Hanaulux 2000 ALPHASTAR; YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA Accessory to MAQUET OR Tables, Product no. 1005.XX ORCHIDE 3D ORCHIDE Maquet Orchide ORCHIS Models 5524, 5618, 5624 Warming Cabinet LUCEA 10 LUCEA 40 LUCEA 50 LUCEA LED Hanaulux 2005 Model CM320 Models 9120, 9122, 9125 and 9128 Models 46-4, 46-5 Aquadis 56 washer disinfector Getinge Aquadis Index Models 9120E, 9122E, 9125E, 9127E, 9128E, 9128EW Models 8666, 8668, S-8668T LUCEA 100 PRISMALIX w/ ENERGIX PRISMALIX

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198