BEUDAMED
    3,080 results · 47ms · Sources: EU EUDAMED, US FDA

    IT/IF Control

    FDA UDI
    SEBIA·03607360023006·Control for the detection and characterization ...

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

    Proov

    FDA UDI
    Mfb Fertility, Inc.·00850035206126·At home fertility test that measures all 4 cycl...

    LBH Advanced BioServices AB

    Importer
    🇸🇪 Sweden·2 Manufacturers

    Beurer

    FDA UDI
    BEURER NORTH AMERICA, L.P.·00850003500478·Beurer Fertility Convenience Kit with Pearl App...

    Magnetic Immunoassay System

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Shenzhen BOSH Diagnostics, Ltd.·1 device

    Liver Fibrosis Multi Control

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·myChoice HRD CDx

    Validate

    FDA UDI
    Lgc Clinical Diagnostics, Inc.·00859110005814·Validate Fertility 1 is intended for the quanti...

    Validate

    FDA UDI
    Lgc Clinical Diagnostics, Inc.·00850011135297·Validate Fertility 1 is intended for the quanti...

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·myChoice CDx

    OT80-Beurer Ovulation Predictor and Fertility Tracking Kit

    FDA UDI
    Equinox Biotech Co., Ltd.·06938444982498·

    LFB BIOMEDICAMENTS

    System producer
    🇫🇷 France

    Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

    FDA classification
    FDA Class 2 ·Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

    Kappa, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Kappa, Antigen, Antiserum, Control

    Test, Urea Adult And Pediatric (Breath),

    FDA classification
    FDA Class 3 ·Test, Urea Adult And Pediatric (Breath),

    Proov

    FDA UDI
    Mfb Fertility, Inc.·00850035206164·A comprehensive screening kit that analyzes key...

    ProGRP（CLIA）、ProGRP Calibrators、ProGRP Control

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

    VID74-

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands, RADIESSE® (+) Lidocaine, RADIESSE (+) Jawline