BEUDAMED
    EU Manufacturer 🇰🇷 South Korea Active

    NanoEntek, Inc.

    SRN: KR-MF-000021903 · Seohae-ro 851-14, 18531 Hwaseong-si, South Korea
    View on EUDAMED
    Basic UDI-DIs
    57
    Total Devices
    68
    On Market
    68
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    21

    Basic Information

    Address
    Seohae-ro 851-14, 18531 Hwaseong-si, South Korea
    Email
    [email protected]
    Phone
    +82 010 8785 7859
    Website
    http://www.nanoentek.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 50
    Eu Ivdr 7
    Classification
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    Eu Ivd General 49
    Eu Ivd Class A 7
    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    Expired / Withdrawn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 064393 0011 Apr 10, 2025

    Market Presence

    Devices from this manufacturer are available in 21 countries across Europe.

    🇦🇹 Austria 🇧🇪 Belgium 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇱🇹 Lithuania 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇹🇷 Türkiye

    Device Portfolio

    Name
    ADAM-rWBC
    ADAM-rWBC HT
    ADAM-rWBC Kit
    ADAM-rWBC Kit
    ADAM-rWBC2
    ADAMII
    ADAMII-CD34 Kit
    ADAMII™-CD3/CD4/CD8 Kit
    AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
    BioTracer™ Dengue Combo Rapid Card
    BioTracer™ Dengue NS1 Ag Rapid Card
    BioTracer™ Influenza A&B Rapid Card
    BioTracer™ Influenza A&B Test
    BioTracer™Dengue IgG/IgM Rapid Card
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    C-Chip
    COVID-19 IgG/IgM Control LQ
    COVID-19 Neutralization Ab Control LQ
    COVID-19 SP Control LQ
    COVID-19 total Ab Control LQ
    Cardiac Marker Control FD Level 1&2
    En-swer™ COVID-19 RT-PCR Kit
    FIC-CGSW
    FREND AP
    FREND BNP
    FREND COVID-19 Ag
    FREND COVID-19 Ag
    FREND COVID-19 Ag
    FREND Cardiac Triple
    FREND D-Dimer
    FREND FLU A&B
    FREND Free T4
    FREND Free T4
    FREND PCT
    FREND PSA Plus
    FREND System
    FREND TSH
    FREND Testosterone
    FREND Testosterone
    FREND Thyroid Duo
    FREND Thyroid Duo
    View all 68 devices →