BEUDAMED
    10,000 results · 42ms · Sources: EU EUDAMED, US FDA

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    One Step HCG Pregnancy Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·AccuBioTech Co., Ltd.·1 device

    ChestEye

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Oxipit, UAB·1 device

    OTO-THERM gyógysapka betét

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·SANATIO Egészségügyi és Kereskedelmi Bt.·3 devices

    OTO-THERM gyógysapka

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·SANATIO Egészségügyi és Kereskedelmi Bt.·5 devices

    Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

    FDA classification
    FDA Class 2 ·Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

    Arterial Blood Sampling Kit

    FDA classification
    FDA Class 1 ·Arterial Blood Sampling Kit

    Factor Xiii A, S, Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Factor Xiii A, S, Antigen, Antiserum, Control

    Ldt, Approved By Nys Clep

    FDA classification
    FDA Not Classified ·Ldt, Approved By Nys Clep

    2022/MDD

    Certificate
    MDD Annex II (excluding section 4)·Idrom LT S.L.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·1 Basic UDI-DI

    Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    NEBULIZZATORE CORTO SMALL PER COLLA CHIRURGICA GLUBRAN 2

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·GEM SRL·1 device

    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

    Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    Ldt, Unmet Need Within An Integrated Healthcare System

    FDA classification
    FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

    Red-Violet Lb

    FDA classification
    FDA Class 1 ·Red-Violet Lb

    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

    Rocket Medical GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    Isansys Lifecare Europe GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer·16 Devices

    BZT-TCP Certification GmbH

    Authorized representative
    🇩🇪 Germany·2 Manufacturers

    Positrigo Germany GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer