BEUDAMED
    2,629 results · 47ms · Sources: EU EUDAMED, US FDA

    DIH GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·llesto 7 VT-T / 5 VR-T , 7 VR-T DX; Ifora 7 VR-T /5 VR-T /7 VR-T DX , 5 VR-T DX ; Itrevia 7 VT-T/ DX (GBLi), Intica 5 VR

    US19/819943492

    Certificate
    MDD Annex II (excluding section 4)·DGH Technology, Inc.·SGS Belgium NV·5 Basic UDI-DIs

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

    COBAS INTEGRA REAGENT CASSETTES

    FDA registration
    ROCHE DIAGNOSTICS GMBH·5 products·🇩🇪 Germany

    DxCare Prescriptions Multimodales

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

    ORBIS Clinical Support

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

    DeepUnity Viewer

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

    DeepUnity PACSonWEB

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

    DeepUnity Diagnost

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

    ORBIS Anesthesia

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

    ORBIS Medication

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

    ORBIS ICU-Manager

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

    clinalytix

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·DH Healthcare GmbH·5 devices

    DIH Technology d.o.o.

    Importer
    🇸🇮 Slovenia·1 Manufacturer

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCHRONY MODELS PARAGON III/PHOENIX III PACERS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·ENPULSE INPLANTABLE PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGYST II PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR-

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Solia S Leads