BEUDAMED
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    OK biotech co., Ltd

    Manufacturer
    🇹🇼 Taiwan·1 Basic UDI-DI·1 Device·1 Importer·TÜV SÜD Product Service GmbH

    OK BIOTECH CO., LTD.

    FDA registration
    OK BIOTECH CO., LTD.·10 products·🇹🇼 Taiwan

    Solus V2 Blood Glucose Monitoring System

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·OK biotech co., Ltd·On the market

    OK METER BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Solus V2 Blood Glucose Monitoring System

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·OK biotech co., Ltd·1 device

    V1 063505 0063

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·OK biotech co., Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    AViTA Corporation

    Manufacturer
    🇹🇼 Taiwan·45 Basic UDI-DIs·67 Devices·2 Importers·SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY

    Tyson Bioresearch, Inc.

    Manufacturer
    🇹🇼 Taiwan·24 Basic UDI-DIs·24 Devices·1 Importer·Eurofins Electric & Electronics Finland Oy and Eurofins Electric & Electronics Finland Oy

    Leltek Inc.

    Manufacturer
    🇹🇼 Taiwan·4 Basic UDI-DIs·4 Devices·DNV Product Assurance AS and SGS FIMKO OY

    Leltek

    Device
    EU MDD · Eu Md Class 2a ·Leltek Inc.·On the market·3 countries

    Tensiomètre au poignet

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·1 country

    Wrist Type Blood Pressure Monitor

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·1 country

    NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·1 country

    NASAL IRRIGATION SOLUTIONS

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·6 countries

    NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·1 country

    NASAL IRRIGATION SOLUTIONS

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·2 countries

    NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·2 countries

    NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·2 countries

    NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·2 countries

    TEMPERATURE MONITORING CUTANEOUS PROBES

    Device
    EU MDD · Eu Md Class 2a ·AViTA Corporation·On the market·2 countries