BEUDAMED
    Notified Body NB 1011 🇭🇺 Hungary

    NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)

    Albert Flórián út 3. A. ép, H-1097 Budapest, Hungary
    View on EUDAMED
    Updated Oct 10, 2024
    Certificates
    27
    Valid
    0
    Expiring < 6mo
    0
    Expired
    27
    Basic UDI-DIs
    485
    Devices
    485
    Manufacturers
    11
    Cert. Types
    5

    Basic Information

    Address
    Albert Flórián út 3. A. ép, H-1097 Budapest, Hungary
    Email
    [email protected]
    Phone
    +36-20-268-7595
    Website
    www.emki.hu

    Regulatory Overview

    Regulation
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    Eu Mdd 484
    Eu Ivdd 1
    Classification
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    Eu Md Class 2b 439
    Eu Md Class 2a 38
    Eu Md Class 3 7
    Eu Ivd Annex 2 List A 1
    Device Types
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    Certificate Health

    Total
    27
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    27
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex III Section 6 HU/CA01/54096/13 Dec 18, 2013
    MDD Annex II Section 4 5-824-200-1707 Jul 29, 2022
    MDD Annex II (excluding section 4) 5-859-200-1812 Dec 11, 2023
    MDD Annex II (excluding section 4) 5-863-200-1902 Feb 14, 2024
    MDD Annex VI 5-867-600-1907 May 26, 2024
    MDD Annex II (excluding section 4) 5-926-200-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-926-200-2015 May 26, 2024
    MDD Annex II (excluding section 4) 5-926-220-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-926-200-2601 May 26, 2024
    MDD Annex II (excluding section 4) 5-926-200-2106 May 26, 2024
    MDD Annex II (excluding section 4) 5-906-200-2103 May 26, 2024
    MDD Annex II (excluding section 4) No. 5-903-200-2103 May 26, 2024
    MDD Annex II (excluding section 4) No. 5-903-200-2123 May 26, 2024
    MDD Annex II Section 4 No. 5-927-204-2105 May 26, 2024
    MDD Annex II Section 4 No. 5-904-204-2103 May 26, 2024
    MDD Annex II Section 4 No. 5-905-204-2103 May 26, 2024
    MDD Annex II (excluding section 4) 5*-926-200-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-296-200-2105 May 26, 2024
    MDD Annex V 5-883-500-2006 May 26, 2024
    MDD Annex II (excluding section 4) 5-926+200-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-921-200-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-929-200-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-923-200-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-9269-200-2105 May 26, 2024
    MDD Annex II (excluding section 4) 5-926-2200-2105 May 26, 2024
    MDD Annex II Section 4 5-909-204-2103 May 26, 2024
    MDD Annex II (excluding section 4) 5-920-200-2105 May 26, 2024

    Manufacturer Portfolio

    Manufacturer Certificates
    FIXIER SA DE CV 13
    Biotech GmbH 5
    Biolab Zrt 1
    Oculus Technologies of México S.A. de C.V. 1
    MDE Kft. 1
    Pharmico Medical Korlátolt felelősségi társaság - MF 1
    Onur Medikal Sanayi ve Ticaret Anonim Şirketi 1
    Newmars Technologies kft 1
    BIOCERAMED - CERÂMICOS PARA APLICAÇÕES MÉDICAS, S.A. 1
    Inuvet GmbH 1
    Echo-Son SA 1