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    MANI, INC.

    Manufacturer
    🇯🇵 Japan·25 Importers·TÜV Rheinland LGA Products GmbH

    SUNWA LTD.

    Manufacturer
    🇯🇵 Japan

    MANI, INC. (HEAD OFFICE)

    FDA registration
    MANI, INC. (HEAD OFFICE)·20 products·🇯🇵 Japan

    MANI, INC. (TAKANEZAWA FACILITY)

    FDA registration
    MANI, INC. (TAKANEZAWA FACILITY)·8 products·🇯🇵 Japan

    MANI, INC. (HANAOKA FACTORY)

    FDA registration
    MANI, INC. (HANAOKA FACTORY)·2 products·🇯🇵 Japan

    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

    HZ 2100551-1

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

    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

    FDA Enforcement
    Class II ·Terminated·Mani, Inc. - Kiyohara Facility·December 16, 2020

    MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S

    FDA Enforcement
    Class II ·Terminated·Mani, Inc. - Kiyohara Facility·December 16, 2020

    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

    FDA Enforcement
    Class II ·Terminated·Mani, Inc. - Kiyohara Facility·May 3, 2023