BEUDAMED
    33 results · 21ms · Sources: EU EUDAMED, US FDA

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    MAC 800 Resting ECG Analysis System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026

    Dental Zirconia Block

    Device
    EU MDD · Eu Md Class 2a ·Shenzhen Yurucheng Dental Materials Co., Ltd.·On the market·2 countries

    CLINICAL CHEMISTRY REAGENTS - OTHER

    Device
    EU IVDR · Eu Ivd Class A ·Singlera Medical Technologies Co.,Ltd.·On the market

    CLINICAL CHEMISTRY REAGENTS - OTHER

    Device
    EU IVDR · Eu Ivd Class A ·Singlera Medical Technologies Co.,Ltd.·On the market

    ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE

    Device
    EU MDD · Eu Md Class 1 ·Tianjin Zhengtian Medical Instrument Co., Ltd.·On the market·2 countries

    MECHANICAL SURGICAL STAPLERS - OTHER

    Device
    EU MDD · Eu Md Class 2b ·BioHealth Medical Technology Co.Ltd.·On the market·2 countries

    IMPROVACUTER® Evacuated Blood Collection Tube

    Device
    EU IVDD · Eu Ivd General ·Guangzhou Improve Medical Instruments Co., Ltd·On the market·6 countries

    SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)

    Device
    EU MDR · Eu Md Class 1 ·Leboo (Hubei) Healthcare Products Limited·On the market

    Endotracheal Tube

    Device
    EU MDD · Eu Md Class 2a ·Hangzhou Tappa Medical Technology Co , Ltd.·On the market·1 country

    Orthodontic Wires

    Device
    EU MDR · Eu Md Class 2a ·Hangzhou DTC Medical Apparatus Co.,Ltd·On the market·32 countries

    Rapid DOA-10 Panel Test Cup (Split type)

    Device
    EU IVDD · Eu Ivd General ·Xiamen Boson Biotech Co., Ltd.·On the market

    CRYOTHERAPY AND THERMOTHERAPY DEVICES

    Device
    EU MDD · Eu Md Class 1 ·Wuhan Pakcare Bio‐technology Co.,Ltd.·On the market

    Automated Glycohemoglobin Analyzer

    Device
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries

    SZcaremed

    Device
    EU MDD · Eu Md Class 2b ·Shenzhen Caremed Medical Technology Co.,Ltd.·On the market·32 countries

    Sterile Gauze Swab

    Device
    EU MDR · Eu Md Class 1 ·Taizhou Wanghong Hygienic Material Factory·On the market

    Thermal Cycler

    Device
    EU IVDR · Eu Ivd Class A ·Nanjing Poweam Medical Co., Ltd·On the market·32 countries

    MEDICAL USE FACE MASKS, TYPE II AND IIR

    Device
    EU MDR · Eu Md Class 1 ·Xiantao Rayxin Medical Products Co. Ltd.·On the market