BEUDAMED
    Notified Body NB 2934 🇵🇱 Poland

    CeCert Sp. z o.o.

    ul. Warecka 11a, 00-034 Warszawa, Poland
    View on EUDAMED
    Updated Dec 6, 2022
    Certificates
    28
    Valid
    0
    Expiring < 6mo
    0
    Expired
    28
    Basic UDI-DIs
    47
    Devices
    47
    Manufacturers
    14
    Cert. Types
    3

    Basic Information

    Address
    ul. Warecka 11a, 00-034 Warszawa, Poland
    Email
    [email protected]
    Phone
    +48 721-721-527

    Regulatory Overview

    Regulation
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    Eu Ivdd 47
    Classification
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    Eu Ivd Self Testing 26
    Eu Ivd Annex 2 List A 16
    Eu Ivd Annex 2 List B 3
    Eu Ivd General 2
    Device Types
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    Certificate Health

    Total
    28
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    28
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV Section 4 CeCert/115/W/E.1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/116/W/E.1 May 26, 2025
    IVDD Annex IV Section 4 CeCert/117/W/E.1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/118/W/E.1 May 26, 2025
    IVDD Annex IV Section 4 CeCert/119/W/E.1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/120/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/068/W/E.2 May 26, 2025
    IVDD Annex IV Section 4 CeCert/077/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CECERT/073/W/E.2 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/097/W/E.1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/102/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/086/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/091/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/092/W/E.2 May 26, 2025
    IVDD Annex III Section 6 CeCert/082/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/126/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/100/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/025/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/081/W/E.4 May 26, 2025
    IVDD Annex III Section 6 CeCert/113/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/057/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/036/W/E.1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/043/W/E.1 May 27, 2025
    IVDD Annex IV Section 4 CeCert/042/W/E.1 May 27, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/045/W/E.1 May 27, 2025
    IVDD Annex IV Section 4 CeCert/044/W/E.1 May 27, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/072/W/E.1 May 27, 2025
    IVDD Annex III Section 6 CeCert/037/W/E.1 May 27, 2025

    Manufacturer Portfolio

    Manufacturer Certificates
    Sansure Biotech Inc. 6
    Daan Gene Co., Ltd. 5
    Hangzhou Realy Tech Co.,Ltd. 3
    Assure Tech. (Hangzhou) Co., Ltd. 2
    Hangzhou Alltest Biotech.Co.,Ltd. 2
    Shenzhen Microprofit Biotech Co., Ltd. 2
    Hangzhou Laihe Biotech Co., Ltd. 1
    Suny (Xiamen) Biotechnology Co., Ltd. 1
    Shenzhen Zijian Biotechnology Co., Ltd 1
    Fosun Diagnostics (Shanghai) Co., Ltd. 1
    Shenzhen Huian Biosci Technology Co., Ltd. 1
    Dynamiker Biotechnology (Tianjin) Co., Ltd. 1
    Zhongshan Bio-Tech Co., Ltd. 1
    Merlin Biomedical (Xiamen) Co., Ltd. 1