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

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    Bundle - One-On-One Studio Starter 2ST-11001

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·21 countries

    SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24

    FDA 510(k)
    FDA Class 2 ·Dental

    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017

    Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C

    FDA Enforcement
    Class II ·Ongoing·AMD Medicom Inc.·June 24, 2026

    ORAgene (Swab-based DNA & Dx Collection Device)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

    Testosterone Saliva ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Testosterone ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Resistin ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Prolactin (PRL) ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Progesterone ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Progesterone Saliva ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Free Estriol ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Anti-Thyroglobulin (Anti-Tg) ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI COVID ANTIBODY TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI HIV ANTIBODY SELF-TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HIV ANTIBODY SELF-TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device