BEUDAMED
    4,140 results · 46ms · Sources: EU EUDAMED, US FDA

    GO-ON Medical Device– Italy (HTL)

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Rottapharm Ltd·1 device

    GO-ON Medical Device- Austria (HTL)

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Rottapharm Ltd·1 device

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME

    GO-ON Medical Device–Polish Market (HTL)

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Rottapharm Ltd·1 device

    GO-ON Medical Device– Belgian Market (HTL)

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Rottapharm Ltd·1 device

    GO-ON Medical Device– French Market (HTL)

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Rottapharm Ltd·1 device

    GO-ON Medical Device– Portuguese Market (HTL)

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Rottapharm Ltd·1 device

    GO-ON Medical Device– German Market (HTL)

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Rottapharm Ltd·1 device

    Klic10 Blood Collection Accessories Set Z

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·1 device

    HTH Products GmbH

    Importer
    🇩🇪 Germany

    HTL-Strefa S.A.

    Importer
    🇵🇱 Poland

    HTD Medical s.r.l.

    Importer
    🇮🇹 Italy·1 Manufacturer

    CERT3GLOBAL, UNIPESSOAL, LDA.

    Authorized representative
    🇵🇹 Portugal·13 Manufacturers·69 Devices

    84587CE01

    Certificate
    MDD Annex II (excluding section 4)·HTL-Strefa S.A.·TÜV Rheinland LGA Products GmbH·7 Basic UDI-DIs

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST

    HEARTWAY POWER MOBILITY SCOOTER, S12

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HEARTWAY POWER CHAIR, P23

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Hypertension Multi Control

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

    Protective layer film

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Monsters Ink HQ Limited·1 device