BEUDAMED
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    Device
    EU MDR · Eu Md Class 1 ·Omnitor AB·On the market

    NOT!FY

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Omnitor AB·1 device

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 2a ·FRENDA AB·On the market·1 country

    VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Airsonett AB·On the market·7 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 2a ·Journalia AB·On the market·1 country

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 2a ·Cambio Healthcare Systems AB·On the market·1 country

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 2a ·Cambio Healthcare Systems AB·On the market·2 countries

    Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable

    FDA Enforcement
    Class II ·Ongoing·C-RAD POSITIONING AB·January 21, 2026

    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

    FDA Enforcement
    Class II ·Ongoing·C-RAD POSITIONING AB·June 4, 2025

    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·August 29, 2018

    RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0)

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·December 23, 2020

    Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.

    FDA Enforcement
    Class II ·Terminated·Etac Supply Center Ab·August 19, 2015

    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·August 29, 2018

    Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

    FDA Enforcement
    Class II ·Ongoing·Getinge Disinfection Ab·October 8, 2025

    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·July 1, 2020

    RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026