BEUDAMED
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    Prometheus Bio Inc.

    Manufacturer
    🇨🇳 China

    Stratagene MX 3000P, ABI 7500,Bio-Rad CFX96

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·1 device

    CeCert/068/W/E.2

    Certificate
    IVDD Annex III Section 6·Hangzhou Laihe Biotech Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/077/W/E.1

    Certificate
    IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    HX 2074650-1

    Certificate
    IVDR QMS·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH

    HL 2074650-1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

    2020-IVD/DE-006/A

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

    CeCert/100/W/E.1

    Certificate
    IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/025/W/E.1

    Certificate
    IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/081/W/E.4

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    1434-IVDD-078/2022

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    244409553-200

    Certificate
    IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    1434-IVDD-010/2022

    Certificate
    IVDD Annex III Section 6·Jiangsu Mole Bioscience Co., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    HL 202746520-1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    HL 202746520-1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    HL 2069313-1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Hangzhou Laihe Biotech Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    CeCert/036/W/E.1

    Certificate
    IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    EU-TDA-FI-20642-800030-2025-1

    Certificate
    IVDR Technical Documentation·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·Sertio Oy·1 Basic UDI-DI

    DE/CA20/01-IVD-Luxuslebenswelt-1187/22

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-076/2022

    Certificate
    IVDD Annex III Section 6·Shanghai BioGerm Medical Technology Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs