BEUDAMED
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    BODY ICING

    Manufacturer
    🇫🇷 France

    ICE COMPRESSION

    Device
    EU MDD · Eu Md Class 2a ·MKS PARIS·On the market·1 country

    STRAP4U ICE COMFORT

    Device
    EU MDR · Eu Md Class 1 ·CREATION XXI·On the market·1 country

    POD STRAP4U ICE HOT HEALTH

    Device
    EU MDR · Eu Md Class 1 ·CREATION XXI·On the market·1 country

    POD STRAP4U ICE COMFORT DENT

    Device
    EU MDR · Eu Md Class 1 ·CREATION XXI·On the market·1 country

    POD STRAP4U ICE COMFORT S

    Device
    EU MDR · Eu Md Class 1 ·CREATION XXI·On the market·1 country

    POD STRAP4U ICE COMFORT D.M.P.

    Device
    EU MDR · Eu Md Class 1 ·CREATION XXI·On the market·1 country

    POD STRAP4U ICE HOT HEALTH DENT

    Device
    EU MDR · Eu Md Class 1 ·CREATION XXI·On the market·1 country

    STRAP4U ICE HOT HEALTH DENT X2

    Device
    EU MDR · Eu Md Class 1 ·CREATION XXI·On the market·1 country

    ICE COMPRESSION FIRST, DUO, & MOOVE Systems

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STRAP4U ICE COMFORT

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·CREATION XXI·1 device

    STRAP4U ICE COMFORT S

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·CREATION XXI·7 devices

    BERERHI ines

    Authorized representative
    🇫🇷 France·1 Manufacturer·15 Devices

    STRAP4U ICE HOT HEALTH DENT X2

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·CREATION XXI·3 devices

    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.

    FDA Enforcement
    Class II ·Terminated·Normand Informatique·December 20, 2017

    INNOPHTA - EMGIDI

    Importer
    🇫🇷 France·4 Manufacturers

    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

    FDA Enforcement
    Class II ·Terminated·ELITech Clinical Systems SAS·August 8, 2018

    ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·March 29, 2017

    ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·March 29, 2017

    ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·March 29, 2017