BEUDAMED
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    Otsuka Electronics Co., Ltd.

    Manufacturer
    🇯🇵 Japan·6 Basic UDI-DIs·6 Devices·5 Importers·TÜV SÜD Product Service GmbH

    OTSUKA ELECTRONICS CO., LTD.

    FDA registration
    OTSUKA ELECTRONICS CO., LTD.·3 products·🇯🇵 Japan

    POCone Infrared Spectrophotometer

    FDA UDI
    OTSUKA ELECTRONICS CO.,LTD.·04987035343417·The POCone Infrared Spectrophotometer is an in ...

    POC-AS10 Auto sampler

    FDA UDI
    OTSUKA ELECTRONICS CO.,LTD.·04987035388517·The POC-ASI10 Auto sampler expands the number o...

    UBIT-IR300 INFRARED SPECTROPHOTOMETER

    FDA Adverse Event
    Malfunction ·OTSUKA ELECTRONICS CO. LTD.·Product code JJQ·November 13, 2007

    AA01

    Device
    EU IVDR · Eu Ivd Class A ·Otsuka Electronics Co., Ltd.·On the market

    POConePlus-AS10

    Device
    EU IVDR · Eu Ivd Class A ·Otsuka Electronics Co., Ltd.·On the market·1 country

    Adamonitor SC

    Device
    EU MDD · Eu Md Class 2b ·Otsuka Electronics Co., Ltd.·On the market·9 countries

    NS-Prime

    Device
    EU IVDR · Eu Ivd Class A ·Otsuka Electronics Co., Ltd.·On the market·2 countries

    POConePlus Infrared Spectrophotometer

    Device
    EU IVDR · Eu Ivd Class B ·Otsuka Electronics Co., Ltd.·On the market·1 country

    Adastand ODT-SC001

    Device
    EU MDR · Eu Md Class 1 ·Otsuka Electronics Co., Ltd.·On the market·9 countries

    UBIT-IR300 INFRARED SPECTROPHOTOMETER

    FDA Adverse Event
    Malfunction ·OTSUKA ELECTRONICS CO., LTD.·Product code JJQ·March 12, 2010

    UBIT-IR300 INFRARED SPECTROPHOTOMETER

    FDA Adverse Event
    Malfunction ·OTSUKA ELECTRONICS CO. LTD.·Product code JJQ·July 8, 2008

    Discrete Clinical Chemistry Analyzer AA01

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Otsuka Electronics Co., Ltd.·1 device

    POConePlus-AS10

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Otsuka Electronics Co., Ltd.·1 device

    Discrete Clinical Chemistry Analyzer NS-Prime

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Otsuka Electronics Co., Ltd.·1 device

    Adastand ODT-SC001

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Otsuka Electronics Co., Ltd.·1 device

    Adamonitor SC

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Otsuka Electronics Co., Ltd.·1 device

    POConePlus Infrared Spectrophotometer

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Otsuka Electronics Co., Ltd.·1 device

    G1 028492 0050

    Certificate
    MDD Annex II (excluding section 4)·Otsuka Electronics Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI