BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    CHENGDU ONE-CHIP BIOTECHNOLOGY CO., LTD.

    Manufacturer
    🇨🇳 China

    One Top Protective Products Co., Ltd.

    Manufacturer
    🇨🇳 China

    Guangzhou Double One Latex Products Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device

    ONE BEAUTY TECHNOLOGY CO.,LTD.

    FDA registration
    ONE BEAUTY TECHNOLOGY CO.,LTD.·1 product·🇨🇳 China

    B-ONE MEDICAL (SUZHOU) CO., LTD.

    FDA registration
    B-ONE MEDICAL (SUZHOU) CO., LTD.·23 products·🇨🇳 China

    b-ONE Medical (Beijing) Co., Ltd.

    FDA registration
    b-ONE Medical (Beijing) Co., Ltd.·7 products·🇨🇳 China

    Guangzhou Double One Latex Products Co., Ltd.

    FDA registration
    Guangzhou Double One Latex Products Co., Ltd.·1 product·🇨🇳 China

    double one

    Device
    EU MDR · Eu Md Class 1 ·Guangzhou Double One Latex Products Co., Ltd.·On the market·32 countries

    FN-W(IN)-1,FN-W(IN)-2

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Jiaxing Funing Medical Instrument Co.,Ltd.·3 devices

    LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Ebola Virus Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Ebola Virus Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Monkeypox Virus Detection Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Monkeypox Virus Detection Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Monkeypox Virus (MPXV) Fast Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Monkeypox Virus (MPXV) Fast Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    COVID-19 Coronavirus Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    GLTSM001- Latex Probe Covers

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Guangzhou Double One Latex Products Co., Ltd.·1 device

    Human Papillomavirus Real Time PCR Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device