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    Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

    FDA Enforcement
    Class I ·Ongoing·DEWEI MEDICAL EQUIPMENT CO LTD·December 14, 2022

    HUZHOU DEPS MEDICAL DEVICE CO., LTD.

    Manufacturer
    🇨🇳 China

    DEVICES FOR BODY PROTECTION - OTHER

    Device
    EU MDR · Eu Md Class 1 ·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries

    LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS)

    Device
    EU MDR · Eu Md Class 1 ·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries

    ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

    Device
    EU MDR · Eu Md Class 1 ·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries

    DEVICES FOR BODY PROTECTION - OTHER

    Device
    EU MDR · Eu Md Class 1 ·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries

    ARM AND ELBOW PROTECTIONS

    Device
    EU MDR · Eu Md Class 1 ·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries

    DEVICES FOR BODY PROTECTION - OTHER

    Device
    EU MDR · Eu Md Class 1 ·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries

    Daan Gene Co., Ltd.

    Manufacturer
    🇨🇳 China·127 Basic UDI-DIs·194 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

    Hangzhou Realy Tech Co.,Ltd.

    Manufacturer
    🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

    Sansure Biotech Inc.

    Manufacturer
    🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Merlin Biomedical (Xiamen) Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.

    Dynamiker Biotechnology (Tianjin) Co., Ltd.

    Manufacturer
    🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.

    Fosun Diagnostics (Shanghai) Co., Ltd.

    Manufacturer
    🇨🇳 China·5 Basic UDI-DIs·5 Devices·CeCert Sp. z o.o.

    Shenzhen Huian Biosci Technology Co., Ltd.

    Manufacturer
    🇨🇳 China·6 Basic UDI-DIs·6 Devices·CeCert Sp. z o.o.

    Suny (Xiamen) Biotechnology Co., Ltd.

    Manufacturer
    🇨🇳 China·2 Basic UDI-DIs·2 Devices·1 Importer·CeCert Sp. z o.o.

    Dawei Medical (Jiangsu) Co., Ltd.

    Manufacturer
    🇨🇳 China·8 Basic UDI-DIs·8 Devices·TUV NORD Polska Sp. z o.o

    Shenzhen Microprofit Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·13 Basic UDI-DIs·13 Devices·9 Importers·CeCert Sp. z o.o., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV SÜD Product Service GmbH

    Xiamen United Medical Instruments Co., Ltd.

    Manufacturer
    🇨🇳 China·3 Basic UDI-DIs·8 Devices

    Shenzhen Huashengyuan Technology Co., Ltd

    Manufacturer
    🇨🇳 China·6 Basic UDI-DIs·6 Devices