BEUDAMED
    EU Manufacturer 🇹🇼 Taiwan Active

    TBG Biotechnology Corp.

    SRN: TW-MF-000029664 · 13F-1, No. 237, Sec. 1, Datong Rd., Xizhi Dist., 22161 New Taipei City, Taiwan
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    Basic UDI-DIs
    20
    Total Devices
    20
    On Market
    20
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    3

    Basic Information

    Address
    13F-1, No. 237, Sec. 1, Datong Rd., Xizhi Dist., 22161 New Taipei City, Taiwan
    Email
    [email protected]
    Phone
    +886 2 7741 7777
    Website
    www.tbgbio.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 20
    Classification
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    Eu Ivd Annex 2 List B 20
    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    Expired / Withdrawn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) HL 2057895-1 May 26, 2025

    Market Presence

    Devices from this manufacturer are available in 3 countries across Europe.

    🇬🇷 Greece 🇮🇹 Italy 🇵🇹 Portugal

    Device Portfolio

    Name
    HLAssure™ SE A Locus SBT Kit, 24 tests/kit
    HLAssure™ SE B Locus SBT Kit, 24 tests/kit
    HLAssure™ SE DRB1-EX Locus SBT Kit, 24 tests/kit
    HLAssure™ SE DRB345 Locus SBT Kit
    Morgan™ HLA SSP A Typing Kit, 4 tests/tray (40 tests)
    Morgan™ HLA SSP ABC Typing Kit, 1 test/tray (10 tests)
    Morgan™ HLA SSP ABC Typing Kit, 1 tests/tray (20 tests)
    Morgan™ HLA SSP ABC Typing Kit,, 2 tests/tray (20 tests)
    Morgan™ HLA SSP ABCDRDQ Typing Kit, 1 test/tray(10 tests)
    Morgan™ HLA SSP ABCDRDQ Typing Kit, 1 test/tray(20tests)
    Morgan™ HLA SSP ABDR Typing Kit, 1 test/tray(20tests)
    Morgan™ HLA SSP ABDR Typing Kit, 1 tests/tray (10 tests)
    Morgan™ HLA SSP ABDR Typing Kit, 2tests/tray(20tests)
    Morgan™ HLA SSP ABDR Typing Kit, 2tests/tray(40tests)
    Morgan™ HLA SSP B Typing Kit, 2 tests/tray (20 tests)
    Morgan™ HLA SSP B27 Typing Kit, 96 tests/tray (96 tests)
    Morgan™ HLA SSP DRB Typing Kit, 4 tests/tray (20 tests)
    Morgan™ HLA SSP DRB/DQB Typing Kit, 3 tests/tray (30 tests)
    TBG ExProbe™ HLA ABCDRDQ Typing Kit, 10 tests/kit
    TBG ExProbe™ SE HLA B27 Typing Kit, 96 tests./try(96 tests)