BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    Mobile Blood Collection Chair

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·STRUB GMBH·7 devices

    QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·August 2, 2023

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·August 2, 2023

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·August 2, 2023

    Alinity i Anti-HCV Reagent Kit, List Number 08P0521

    FDA Enforcement
    Class II ·Ongoing·Abbott GmbH·April 10, 2024

    ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

    FDA Enforcement
    Class II ·Ongoing·Abbott GmbH·April 10, 2024

    ThEA SARS-CoV-2 plugin

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·RAM THz Solutions GmbH·1 device

    NanoRepro SARS-CoV-2 Antigen Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·December 6, 2017

    NanoRepro SARS-CoV-2 Antigen Schnelltest (DE/EN)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    FR475-Fluhunter: SARS-CoV-2 (Realtime PCR-Kit)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Genekam Biotechnology AG·1 device

    Nilas MV GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer·4 Devices

    NanoRepro SARS-CoV-2 Antigen Schnelltest (20er Kit) [DE/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    NanoRepro SARS-CoV-2 Antigen Schnelltest (5er Kit) [DE/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (20er Kit) [DE/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (5er Kit) [SP/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (1er Kit) [SP/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (20er Kit) [DE/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (5er Kit) [DE/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device

    NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (1er Kit) [DE/EN]

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·NanoRepro AG·1 device