BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    Saline, Vascular Access Flush

    FDA classification
    FDA Class 2 ·Saline, Vascular Access Flush

    Controller, Temperature, Radiographic

    FDA classification
    FDA Class 2 ·Controller, Temperature, Radiographic

    Radioimmunoassay, Cyclic Gmp

    FDA classification
    FDA Class 2 ·Radioimmunoassay, Cyclic Gmp

    Injector, Vertebroplasty (Does Not Contain Cement)

    FDA classification
    FDA Class 1 ·Injector, Vertebroplasty (Does Not Contain Cement)

    Hiv-1 Genotyping Assay Using Ngs Technology

    FDA classification
    FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

    Hemodialysis Tray (Not A Start/Stop Kit)

    FDA classification
    FDA Class 2 ·Hemodialysis Tray (Not A Start/Stop Kit)

    Internal Polymerase Chain Reaction Control, Not Assay Specific

    FDA classification
    FDA Class 1 ·Internal Polymerase Chain Reaction Control, Not Assay Specific

    Mercury Vapor Lamp, Not Self-Extinguishing, R-Type

    FDA classification
    FDA Not Classified ·Mercury Vapor Lamp, Not Self-Extinguishing, R-Type

    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

    FDA classification
    FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

    Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

    FDA classification
    FDA Class 2 ·Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

    Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

    FDA classification
    FDA Not Classified ·Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    FDA classification
    FDA Class 2 ·Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

    FDA classification
    FDA Class 2 ·Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

    FDA classification
    FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

    FDA classification
    FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

    High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

    FDA classification
    FDA Not Classified ·High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

    FDA classification
    FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

    FDA classification
    FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

    Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule