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Risk Class IV
 

Active implantable devices

Adaptor, pacemaker lead, implantable
Bag, pacemaker, implantable
Circulatory assist system external power supply unit
Circulatory assist system software
Circulatory assist system, artificial heart, permanent
Circulatory assist system, artificial heart, temporary
Defibrillator, implantable, automatic
Defibrillator, implantable, automatic, dual-chamber
Electrode, cortical
Electrode/lead, defibrillator, implantable
Electrode/lead, defibrillator/pacemaker, implantable
Electrode/lead, pacemaker, implantable, endocardial
Electrode/lead, pacemaker, implantable, epicardial
Electrode/lead, stimulator, implantable, incontinence
Electrode/lead, stimulator, implantable, myoplasty
Electrode/lead, stimulator, implantable, neurological
Electrode/lead, stimulator, implantable, vagus nerve
Hearing aid, bone-conduction, implanted
Infusion pump, implantable, nonprogrammable
Infusion pump, implantable, programmable
Pacemaker charger
Pacemaker electrode analyser
Pacemaker repair kit
Pacemaker system analyser, implantable
Pacemaker system analyser, invasive
Pacemaker system analyser, magnetic
Pacemaker system analyser, transtelephonic
Pacemaker, cardiac, implantable
Programmer, implantable cardiac pacemaker
Programmer, implantable defibrillator
Programmer, implantable infusion pump
Programmer, implantable stimulator, incontinence
Programmer, implantable stimulator, myoplasty
Programmer, implantable stimulator, neuromuscular
Programmer, implantable stimulator, vagus nerve
Stimulator, electrical, brain, tremor
Stimulator, electrical, cardiac, myoplasty
Stimulator, electrical, neuromuscular, gait, implantable
Stimulator, electrical, neuromuscular, incontinence, implantable
Stimulator, electrical, vagus nerve, antiseizure
Stimulator, electrical, vagus nerve, coma arousal
Test instrument, defibrillator/cardioverter


Anaesthetic and respiratory devices

Arterial blood sampling kit


Electro mechanical medical devices

Angioplasty system *
Angioplasty system, radio-frequency, thermal *
Arterioscope, fibreoptic, reusable
Flowmeter, blood, electromagnetic


Non-active implantable devices

Anastomosis coupler, vascular *
Annuloplasty ring
Cement, orthopaedic, bone
Clip, internal, aneurysm
Contraceptive, drug delivery, implantable
Contraceptive, fallopian tube clip/band
Contraceptive, fallopian tube insert
Contraceptive, vas deferens clip/band
Embolization agent *
Embolization implant inserter *
Embolization implant kit *
Embolization implant, arterial *
Embolization implant, vascular *
Embolization prevention implant, temporary *
Graft, cardiac valve
Prosthesis, intracardiac patch
Prosthesis, mammary, internal, gel-filled
Prosthesis, mammary, internal, inflatable
Prosthesis, valve, cardiac
Prosthesis, vascular *
Scleral buckling device
Stent, cardiovascular *
Stent, iliac


Single-use devices

Dressing, absorbable, adhesion-prevention
Biopsy kit, brain
Burn kit
Cannula, brain
Cannula, coronary artery
Cannula, coronary sinus
Cannula, ventricular
Cardiac insulation pad
Cardioplegia solution administration kit
Catheter, angiography
Catheter, angioplasty, atherectomy *
Catheter, angioplasty, atherectomy, ablative *
Catheter, angioplasty, balloon dilatation *
Catheter, angioplasty, balloon dilatation, coronary perfusing
Catheter, angioplasty, balloon dilatation, heated
Catheter, angioplasty, direct laser ablation *
Catheter, angioplasty, radio-frequency, thermal *
Catheter, cardiac, ablation
Catheter, cardiac, angiography, ventricular
Catheter, cardiac, balloon, intra-aortic
Catheter, cardiac, balloon, pacing electrode
Catheter, cardiac, balloon, pulmonary artery
Catheter, cardiac, balloon, pulmonary artery, oximetric
Catheter, cardiac, balloon, pulmonary artey, thermal dilution
Catheter, cardiac, occluder delivery
Catheter, cardiac, pericardium drainage
Catheter, cardiac, septostomy
Catheter, cardiac, valvuloplasty
Catheter, cerebrospinal
Catheter, hydrocephalic
Catheter, intravascular, occluding *
Catheter, neurological, ventricular
Catheter, perfusion, vascular
Catheter, urological, antimicrobial
Clip, surgical, wound, absorbable
Contraceptive, intra-uterine device
Drain, cerebrospinal
Dressing, antimicrobial
Patch, cardiovascular *
Shunt, carotid artery
Suture, absorbable, synthetic, polyglycolic acid
Suture, catgut, plain
Suture, iodized


Remarks:
1. The above examples of medical devices are for reference only. Descriptions take reference from the format in Global Medical Device Nomenclature (GMDN) System.
2. The actual classification of a particular device must be considered individually, taking account of its design and use intended by the manufacturer.
3. Where a medical device has features that place it into more than one class, conformity assessment should be based on the highest class indicated.
* Class IV only if the medical device involves direct contact with the heart or central circulatory system.
 
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image 2005 copyright logo | Important notices Last revision date: 26 May 2009