BEUDAMED
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    Break-off nut holder

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

    Screw-tab Break off Instrument

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

    Continuous Glucose Monitoring System-SLE-LT-M-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-SHD-DA-M-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-S-GR-G-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-SMD-EN-M-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-S-EN-G-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-S-ROSQ-G-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-SBM-TR-G-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-SAQ-CZSK-M-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·2 countries

    Continuous Glucose Monitoring System-G-BG-M-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-GZA-SI-M-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Continuous Glucose Monitoring System-EEX-RU-M-OFF

    Device
    EU MDR · Eu Md Class 2b ·Shenzhen SiSensing Co., Ltd.·On the market·1 country

    Twist-off Lancet

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Tianjin Huahong Technology Co., Ltd.·103 devices

    Break-off Set Screw

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Shanghai Sanyou Medical Co., Ltd.·1 device

    Multi cut-off THC drug test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Hangzhou Alltest Biotech.Co.,Ltd.·1 device

    Sports Medicine - ACUTEC Snap-off Screw Implant Box

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Tianjin Zhengtian Medical Instrument Co., Ltd.·1 device

    Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018