DD 2068388-1

Certificate

MDD Annex V·INTCO MEDICAL (HK) CO., ltd·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE

Piccolo Liver Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000031·The Piccolo® Liver Panel Plus, used with the Pi...

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Autogen, Vigiliant EL ICD, Perciva ICD, Resonate EL ICD, Perciva HF ICD,

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T & VARIOUS FAMILIES OF LUMAX HF CRT-D's; VARIOUS FAMILIES OF LUMAX DR & VR ICD's

PREPOPlus®

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ORTHOPLUS·45 devices

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN X4; INOGEN X4; ORIGEN X4; AUTOGEN X4; MOMENTUM X4; VIGILIANT X4; RESONATE X4/HF; PUNCTUA; ENERGEN; INCEPTA CRT-D

PICCOLO PRIMARY HEALTH PANEL

FDA registration

ABAXIS, INC.·12 products·🇺🇸 United States

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS

Royal Medix B.V.

Importer

🇳🇱 Netherlands·2 Manufacturers

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 DR-T DF4 ProMRI, Rivacor 3 DR-T DF4 ProMRI, Rivacor 5 DR-T DF4 ProMRI, Rivacor 7 DR-T DF4 ProMRI, Acticor 7 HF

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP

Laboratoires Mayoly Spindler

Importer

🇫🇷 France·1 Manufacturer

METEDA SRL

Importer

🇮🇹 Italy·1 Manufacturer

Matthias Ok - Einzelunternehmen

Importer

🇩🇪 Germany·2 Manufacturers

Algol Trehab Oy

Importer

🇫🇮 Finland·2 Manufacturers

Purawerk GmbH

Importer

🇩🇪 Germany·2 Manufacturers