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

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    OPTILUME URETHRAL DRUG COATED BALLOON

    FDA Adverse Event
    Malfunction ·UROTRONIC, INC.·Product code QRH·March 14, 2025

    OPTILUME BPH CATHETER SYSTEM

    FDA Adverse Event
    Injury ·UROTRONIC INC.·Product code QXB·January 3, 2025

    OPTILUME BPH CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·UROTRONIC INC.·Product code QXB·March 18, 2025

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    OPTILUME PROCEDURE

    FDA Adverse Event
    Injury ·LABORIE/UROTRONIC INC·Product code QXB·June 12, 2025

    OPTILUME BALLOON

    FDA Adverse Event
    Injury ·LABORIE MEDICAL TECHNOLOGIES/UROTRONIC, INC.·Product code QRH·May 6, 2026

    OPTILUME

    FDA Adverse Event
    Injury ·LABORIE MEDICAL TECHNOLOGIES / UROTRONIC INC.·Product code KOE·March 14, 2025

    1434-MDD-033/2021

    Certificate
    MDD Annex II Section 4·Urotronic, Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·6 Basic UDI-DIs

    OPTILUME BPH CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·UROTRONIC INC / LABORIE MEDICAL TECHNOLOGIES CORP.·Product code QXB·May 26, 2026

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    OPTILUME URETHRAL DRUG COATED BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·URONTRONIC INC·Product code QRH·June 5, 2025