BEUDAMED
    EU Manufacturer ๐Ÿ‡ฐ๐Ÿ‡ท South Korea Active

    NanoEntek, Inc.

    SRN: KR-MF-000021903 ยท 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

    Watch NanoEntek, Inc. for changes

    We'll email you when it registers new devices, or a certificate is issued or withdrawn.

    Get notified when NanoEntek, Inc. changes

    We'll email you about new devices, new certificates and withdrawals for this manufacturer.

    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
    Loading...
    Eu Ivdd 50
    Eu Ivdr 7
    Classification
    Loading...
    Eu Ivd General 49
    Eu Ivd Class A 7
    Eu Ivd Annex 2 List B 1
    Device Types
    Loading...

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
    Loading...
    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.

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

    Device Portfolio

    Name
    ADAM-rWBC
    ADAM-rWBC HT
    ADAM-rWBC Kit
    ADAM-rWBC Kit
    ADAM-rWBC2
    ADAMII
    ADAMII-CD34 Kit
    ADAMIIโ„ข-CD3/CD4/CD8 Kit
    AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
    BioTracerโ„ข Dengue Combo Rapid Card
    BioTracerโ„ข Dengue NS1 Ag Rapid Card
    BioTracerโ„ข Influenza A&B Rapid Card
    BioTracerโ„ข Influenza A&B Test
    BioTracerโ„ขDengue 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-swerโ„ข 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 โ†’