BEUDAMED
    EU Manufacturer 🇹🇼 Taiwan Active

    OK biotech co., Ltd

    SRN: TW-MF-000028031 · No. 91, Sec. 2, Gongdao 5th Rd, 30070 Hsinchu City, Taiwan
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    Basic UDI-DIs
    1
    Total Devices
    1
    On Market
    1
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

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    Basic Information

    Address
    No. 91, Sec. 2, Gongdao 5th Rd, 30070 Hsinchu City, Taiwan
    Email
    [email protected]
    Phone
    +886 3 5160258
    Website
    https://www.okbiotech.com/

    Regulatory Overview

    Regulation
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    Eu Ivdd 1
    Classification
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    Eu Ivd Annex 2 List B 1
    Device Types
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    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) V1 063505 0063 May 26, 2025

    Device Portfolio

    Name
    Solus V2 Blood Glucose Monitoring System