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    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

    FDA Enforcement
    Class II ·Completed·Fukuda Denshi Co., Ltd.·December 13, 2017

    Nakanishi Inc.

    System producer
    🇯🇵 Japan

    DZ 2081569-1

    Certificate
    MDR QA·CYBERDYNE Inc.·TÜV Rheinland LGA Products GmbH

    HZ 2100551-1

    Certificate
    MDR QMS·MANI, INC.·TÜV Rheinland LGA Products GmbH

    HD 2029991-1

    Certificate
    MDD Annex II (excluding section 4)·Ziosoft, Inc.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    HZ 2003379-1

    Certificate
    MDR QMS·Konica Minolta, Inc.·TÜV Rheinland LGA Products GmbH

    V1 027591 0045

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·ARKRAY Factory, Inc.·TÜV SÜD Product Service GmbH·141 Basic UDI-DIs

    ASAHI INTECC CO., LTD.

    Manufacturer
    🇯🇵 Japan·1371 Basic UDI-DIs·1371 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    GUNZE LIMITED

    Manufacturer
    🇯🇵 Japan·69 Basic UDI-DIs·69 Devices·3 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    TOP Corporation

    Manufacturer
    🇯🇵 Japan·39 Basic UDI-DIs·97 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    JP19/040495

    Certificate
    MDD Annex II (excluding section 4)·Tokai Medical Products, Inc.·SGS Belgium NV·69 Basic UDI-DIs

    HD 2014410-1

    Certificate
    MDD Annex II (excluding section 4)·AIR WATER REALIZE INC.·TÜV Rheinland LGA Products GmbH·55 Basic UDI-DIs

    G1 016328 0144

    Certificate
    MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    JP20/819943399

    Certificate
    MDD Annex II Section 4·Tokai Medical Products, Inc.·SGS Belgium NV·1 Basic UDI-DI

    G1 016328 0144

    Certificate
    MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·401 Basic UDI-DIs

    G1 016328 0145

    Certificate
    MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

    JP19/040507

    Certificate
    MDD Annex II (excluding section 4)·PIOLAX MEDICAL DEVICES, INC.·SGS Belgium NV·22 Basic UDI-DIs

    SEIKAGAKU CORPORATION

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    SB-KAWASUMI LABORATORIES, INC.

    Manufacturer
    🇯🇵 Japan·408 Basic UDI-DIs·426 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH