| Neonatal positioning/nesting device | | Neonatal positioning/nesting device | | Class I
|
| Neonatal/adult intensive-care ventilator | | Neonatal/adult intensive-care ventilator | | Class IIb
|
| Nephrology information system application software | | Nephrology information system application software | | Class I
|
| Nephroscopic surgical procedure kit, non-medicated, reusable | | Nephroscopic surgical procedure kit, non-medicated, reusable | |
|
| Nephroscopic surgical procedure kit, non-medicated, single-use | | Nephroscopic surgical procedure kit, non-medicated, single-use | |
|
| Nerve-locating system | | Nerve-locating system | | Class IIa
|
| Nerve/vessel retractor | | Nerve/vessel retractor | | Class I
|
| Neuraxial syringe | | Neuraxial syringe | |
|
| Neuraxial syringe | | Neuraxial syringe | | Class I
|
| Neurophysiologic monitoring system | | Neurophysiologic monitoring system | | Class IIa
|
| Neurosurgical bone flap elevator | | Neurosurgical bone flap elevator | | Class I
|
| Neurosurgical probe | | Neurosurgical probe | |
|
| Neurosurgical probe | | Neurosurgical probe | | Class I
|
| Neurosurgical procedure kit, non-medicated, reusable | | Neurosurgical procedure kit, non-medicated, reusable | |
|
| Neurosurgical procedure kit, non-medicated, single-use | | Neurosurgical procedure kit, non-medicated, single-use | |
|
| Neurosurgical retraction system, brain | | Neurosurgical retraction system, brain | | Class I
|
| Neurosurgical retraction system, spinal | | Neurosurgical retraction system, spinal | | Class I
|
| Neurosurgical rongeur | | Neurosurgical rongeur | | Class I
|
| Neurosurgical scissors | | Neurosurgical scissors | | Class I
|
| Neutral pH Detergent Rinse Aid | | Neutral pH Detergent Rinse Aid | | Class I
|
| Neutral plasma wound/lesion disinfection system | | Neutral plasma wound/lesion disinfection system | | Class IIb
|
| Nipple former | | Nipple former | | Class I
|
| Nipple pad, sterile | | Nipple pad, sterile | | Class IIa
|
| Nipple pad/ring, reusable | | Nipple pad/ring, reusable | | Class I
|
| Nipple prosthesis, external | | Nipple prosthesis, external | |
|
| Nipple prosthesis, external | | Nipple prosthesis, external | | Class I
|
| Nipple prosthesis, implantable | | Nipple prosthesis, implantable | |
|
| Nipple shielding teat, reusable | | Nipple shielding teat, reusable | | Class I
|
| Nitrile examination/treatment glove, non-powdered, non-antimicrobial | | Nitrile examination/treatment glove, non-powdered, non-antimicrobial | |
|
| Nitrile examination/treatment glove, non-powdered, non-antimicrobial | | Nitrile examination/treatment glove, non-powdered, non-antimicrobial | | Class I
|
| Nitrile examination/treatment glove, non-powdered, sterile | | Nitrile examination/treatment glove, non-powdered, sterile | | Class I
|
| Nitrile examination/treatment glove, powdered | | Nitrile examination/treatment glove, powdered | | Class I
|
| Nitrile surgical glove, non-powdered | | Nitrile surgical glove, non-powdered | | Class I
|
| Nitrogen plasma skin surface treatment system | | Nitrogen plasma skin surface treatment system | | Class I
|
| Nitrogen terminal unit | | Nitrogen terminal unit | | Class IIa
|
| Nitrous oxide low pressure tubing | | Nitrous oxide low pressure tubing | | Class IIa
|
| Nitrous oxide terminal unit | | Nitrous oxide terminal unit | | Class IIa
|
| Nitrous oxide/oxygen terminal unit | | Nitrous oxide/oxygen terminal unit | | Class IIa
|
| Non-Active Autoinjector Devices | | Non-Active Autoinjector Devices | | Class I
|
| Non-Active Infusion Devices And Accessories | | Non-Active Infusion Devices And Accessories | | Class I
|
| Non-adhesive device retention bandage | | Non-adhesive device retention bandage | |
|
| Non-adhesive device retention bandage | | Non-adhesive device retention bandage | | Class I
|
| Non-constrained polyethylene acetabular liner | | Non-constrained polyethylene acetabular liner | |
|
| Non-constrained polyethylene acetabular liner | | Non-constrained polyethylene acetabular liner | | Class III
|
| Non-corrective tinted spectacles | | Non-corrective tinted spectacles | | Class I
|
| Non-fixed medical gas cylinder regulator | | Non-fixed medical gas cylinder regulator | | Class IIb
|
| Non-heated respiratory humidifier | | Non-heated respiratory humidifier | | Class IIa
|
| Non-Invasive Drainage Devices And Accessories | | Non-Invasive Drainage Devices And Accessories | | Class I
|
| Non-Invasive Electrodes/Transducers And Accessories | | Non-Invasive Electrodes/Transducers And Accessories | | Class I
|
| Non-Invasive Tubing (Waste Disposal) | | Non-Invasive Tubing (Waste Disposal) | | Class I
|
| Non-ISO80369-standardized small-bore linear connector, reusable | | Non-ISO80369-standardized small-bore linear connector, reusable | | Class I
|
| Non-Medicated Emollient Cream/Ointment | | Non-Medicated Emollient Cream/Ointment | | Class I
|
| Non-rebreathing oxygen face mask | | Non-rebreathing oxygen face mask | | Class IIa
|
| Non-rebreathing valve, reusable | | Non-rebreathing valve, reusable | | Class IIa
|
| Non-rebreathing valve, single-use | | Non-rebreathing valve, single-use | | Class IIa
|
| Non-rechargeable public automated external defibrillator | | Non-rechargeable public automated external defibrillator | | Class IIb
|
| Non-rechargeable public semi-automated external defibrillator electrode, adult | | Non-rechargeable public semi-automated external defibrillator electrode, adult | | Class IIb
|
| Non-rechargeable public semi-automated external defibrillator electrode, paediatric | | Non-rechargeable public semi-automated external defibrillator electrode, paediatric | | Class IIb
|
| Non-rechargeable public semi-automated external defibrillator | | Non-rechargeable public semi-automated external defibrillator | | Class IIb
|
| Non-sterile coupling gel | | Non-sterile coupling gel | | Class I Devices |
| Non-sterile scar management dressing, reusable | | Non-sterile scar management dressing, reusable | | Class I Devices |
| Non-sterile scar management dressing, reusable | | Non-sterile scar management dressing, reusable | | NEW EU Medical Devices Regulation 2017/745 |
| Non-sterile scar management dressing, single-use | | Non-sterile scar management dressing, single-use | | Class I Devices |
| Non-vascular catheter introduction set | | Non-vascular catheter introduction set | | Class IIa
|
| Non-wearable adult urine collection bag, closed-ended | | Non-wearable adult urine collection bag, closed-ended | | Class I
|
| Non-wearable adult urine collection bag, closed-ended | | Non-wearable adult urine collection bag, closed-ended | | Class IIb
|
| Non-wearable adult urine collection bag, open-ended | | Non-wearable adult urine collection bag, open-ended | | Class I
|
| Non-wearable urine/faecal collection bag holder | | Non-wearable urine/faecal collection bag holder | | Class I
|
| Non-woven gauze pad, non-sterile | | Non-woven gauze pad, non-sterile | | Class I
|
| Non-woven gauze pad, sterile | | Non-woven gauze pad, sterile | | Class I Devices |
| Non-woven gauze pad, sterile | | Non-woven gauze pad, sterile | |
|
| Non-woven gauze pad, sterile | | Non-woven gauze pad, sterile | | Class I
|
| Non-woven gauze pad, sterile | | Non-woven gauze pad, sterile | | Class IIa
|
| Non-woven gauze roll | | Non-woven gauze roll | | Class I
|
| Non Active Drug Delivery Devices and Accessories | | Non Active Drug Delivery Devices and Accessories | | Class I
|
| Non Medicated Emollient Cream/ Ointment | | Non Medicated Emollient Cream/ Ointment | | Class I
|
| Nonimplantable needle guide, reusable | | Nonimplantable needle guide, reusable | | Class I
|
| Nonimplantable needle guide, single-use | | Nonimplantable needle guide, single-use | | Class I
|
| Nonimplantable needle guide, single-use | | Nonimplantable needle guide, single-use | | Class IIa
|
| Noninvasive blood pressure measurement system | | Noninvasive blood pressure measurement system | | Class IIa
|
| Noninvasive device battery charger | | Noninvasive device battery charger | | Class I
|
| Noninvasive vascular ultrasound system, battery-powered | | Noninvasive vascular ultrasound system, battery-powered | | Class IIa
|
| Nose clip, single-use | | Nose clip, single-use | | Class I
|
| Nose prosthesis, external | | Nose prosthesis, external | |
|
| Nurse call system alarm | | Nurse call system alarm | | Class I
|
| Nylon suture, non-bioabsorbable, monofilament | | Nylon suture, non-bioabsorbable, monofilament | | Class IIb
|
| Nystagmus inducing optokinetic drum | | Nystagmus inducing optokinetic drum | | Class I
|
| O1 | | Erection Assistance Devices/Devices for premature ejaculation | | Class I Devices |
| O1 | | Vacuum Erection Assistance Devices | | Class I Devices |
| O2 | | Vaginal Trainers | | Class I Devices |
| O3 | | Aids For Daily Living (Seating And Support) | | Class I Devices |
| O4 | | Aids For Daily Living (Bathing And Toilet) | | Class I Devices |
| O7 | | Speech / Breathing Training Devices | | Class I Devices |
| O8 | | Wound Manager | | Class I Devices |
| O8 | | Wound Manager | | Class I Devices |
| O9 | | Schirmer Tear Test (Sterile Product) | | Class I Devices |
| Obstetrical decapitation hook | | Obstetrical decapitation hook | | Class I
|
| Obstetrical forceps, reusable | | Obstetrical forceps, reusable | | Class I
|
| Obstetrical/gynaecological surgical procedure kit, medicated | | Obstetrical/gynaecological surgical procedure kit, medicated | |
|
| Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable | | Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable | |
|
| Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable | | Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable | | Class I
|
| Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | | Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | |
|
| Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | | Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | | Class IIa
|
| Obstetrics Forceps (Single Use) | | Obstetrics Forceps (Single Use) | | Class I
|
| Obstetrics information system | | Obstetrics information system | | Class I
|
| Ocular hook/spatula/manipulator, reusable | | Ocular hook/spatula/manipulator, reusable | | Class I
|
| Ocular occluder/Maddox rod | | Ocular occluder/Maddox rod | | Class I
|
| Odour-absorbent dressing, non-antimicrobial | | Odour-absorbent dressing, non-antimicrobial | | Class I
|
| Odour-absorbent dressing, non-antimicrobial | | Odour-absorbent dressing, non-antimicrobial | | Class IIb
|
| Oesophageal bougie, single-use | | Oesophageal bougie, single-use | | Class I
|
| Oesophageal varices haemostatic tube | | Oesophageal varices haemostatic tube | | Class I
|
| Olive Oil Ear Drops ( for transient use) | | Olive Oil Ear Drops ( for transient use) | | Class I
|
| Olive Oil for Treating Ear Wax | | Olive Oil for Treating Ear Wax | | Class I
|
| One-piece intestinal ostomy bag, closed-ended | | One-piece intestinal ostomy bag, closed-ended | | Class I
|
| One-piece intestinal ostomy bag, open-ended | | One-piece intestinal ostomy bag, open-ended | | Class I
|
| One-piece urostomy bag, closed-ended | | One-piece urostomy bag, closed-ended | | Class I
|
| One-piece urostomy bag, open-ended | | One-piece urostomy bag, open-ended | | Class I
|
| Open-ended non-wearable urine collection bag, non-sterile | | Open-ended non-wearable urine collection bag, non-sterile | | Class I
|
| Open-ended non-wearable urine collection bag, sterile | | Open-ended non-wearable urine collection bag, sterile | | Class I Devices |
| Open-ended wearable urine collection bag, non-sterile | | Open-ended wearable urine collection bag, non-sterile | | Class I
|
| Open-surgery adhesive/sealant applicator, dual-channel | | Open-surgery adhesive/sealant applicator, dual-channel | | Class IIa
|
| Open-surgery biopsy forceps, reusable | | Open-surgery biopsy forceps, reusable | | Class I
|
| Open-surgery dissector | | Open-surgery dissector | | Class I
|
| Open-surgery electrosurgical electrode, monopolar, reusable | | Open-surgery electrosurgical electrode, monopolar, reusable | | Class I
|
| Open-surgery electrosurgical electrode, monopolar, single-use | | Open-surgery electrosurgical electrode, monopolar, single-use | | Class IIb
|
| Open-surgery electrosurgical handpiece/electrode, bipolar, single-use | | Open-surgery electrosurgical handpiece/electrode, bipolar, single-use | | Class IIb
|
| Open-surgery electrosurgical handpiece/electrode, monopolar, single-use | | Open-surgery electrosurgical handpiece/electrode, monopolar, single-use | | Class IIb
|
| Open-surgery ligation clip applier | | Open-surgery ligation clip applier | | Class I
|
| Open-surgery manual linear cutting stapler, reusable | | Open-surgery manual linear cutting stapler, reusable | | Class I
|
| Open-surgery manual linear cutting stapler, single-use | | Open-surgery manual linear cutting stapler, single-use | | Class IIa
|
| Open-surgery manual linear cutting stapler, single-use | | Open-surgery manual linear cutting stapler, single-use | | Class IIb
|
| Open-surgery manual linear stapler, single-use | | Open-surgery manual linear stapler, single-use | | Class IIa
|
| Open-surgery manual linear stapler, single-use | | Open-surgery manual linear stapler, single-use | | Class IIb
|
| Open-surgery stone-retrieval forceps | | Open-surgery stone-retrieval forceps | | Class I
|
| Operating light | | Operating light | | Class I Devices |
| Operating room audiovisual data/device management system | | Operating room audiovisual data/device management system | | Class I Devices |
| Operating room gown, single-use | | Operating room gown, single-use | | Class I Devices |
| Operating Room Microscopes/Magnification Systems and Accessories | | Operating Room Microscopes/Magnification Systems and Accessories | | Class I
|
| Operating Room Microscopes/Magnification Systems | | Operating Room Microscopes/Magnification Systems | | Class I
|
| Operating room stool | | Operating room stool | | Class I
|
| Operating shadowless light | | Operating shadowless light | | Class I Devices |
| Operating table accessory trolley | | Operating table accessory trolley | |
|
| Operating table accessory trolley | | Operating table accessory trolley | | Class I
|
| Operating table accessory trolley | | Operating table accessory trolley | | Class I Devices |
| Operating table mattress, basic | | Operating table mattress, basic | | Class I
|
| Operating table patient pressure distribution pad, reusable | | Operating table patient pressure distribution pad, reusable | | Class I
|
| Operating table patient pressure distribution pad, single-use | | Operating table patient pressure distribution pad, single-use | | Class I
|
| Operating table sheet, single-use | | Operating table sheet, single-use | | Class I Devices |
| Operating table top trolley | | Operating table top trolley | | Class I
|
| Operating Tables And Accessories | | Operating Tables And Accessories | | Class I
|
| Operating table, | | Operating table, | | Class I Devices |
| Operation light | | Operation light | | Class I Devices |
| Operative-site suture holder | | Operative-site suture holder | | Class I
|
| Operative-site suture holder | | Operative-site suture holder | | Class IIa
|
| Ophthalmascopes/Retinascopes | | Ophthalmascopes/Retinascopes | | Class I
|
| Ophthalmic angular gauge, reusable | | Ophthalmic angular gauge, reusable | | Class I
|
| Ophthalmic binocular gauge | | Ophthalmic binocular gauge | | Class I
|
| Ophthalmic calliper | | Ophthalmic calliper | | Class I
|
| Ophthalmic cannulation set, reusable | | Ophthalmic cannulation set, reusable | | Class I
|
| Ophthalmic cannulation set, single-use | | Ophthalmic cannulation set, single-use | | Class IIa
|
| Ophthalmic chair, manual | | Ophthalmic chair, manual | |
|
| Ophthalmic curette, reusable | | Ophthalmic curette, reusable | | Class I
|
| Ophthalmic examination station | | Ophthalmic examination station | | Class I
|
| Ophthalmic examination target holder | | Ophthalmic examination target holder | | Class I
|
| Ophthalmic fundus camera | | Ophthalmic fundus camera | | Class I
|
| Ophthalmic implant handling forceps, reusable | | Ophthalmic implant handling forceps, reusable | | Class I
|
| Ophthalmic Instrument Support Tables | | Ophthalmic Instrument Support Tables | | Class I
|
| Ophthalmic instrument table, line-powered | | Ophthalmic instrument table, line-powered | | Class I
|
| Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable | | Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable | | Class I
|
| Ophthalmic knife, reusable | | Ophthalmic knife, reusable | | Class I
|
| Ophthalmic knife, single-use | | Ophthalmic knife, single-use | | Class IIa
|
| Ophthalmic Measurement Device | | Ophthalmic Measurement Device | | Class I
|
| Ophthalmic needle, single-use | | Ophthalmic needle, single-use | | Class IIa
|
| Ophthalmic refractometer, automated | | Ophthalmic refractometer, automated | | Class I Devices |
| Ophthalmic slit lamp, examination | | Ophthalmic slit lamp, examination | | Class I
|
| Ophthalmic slit lamp, surgical | | Ophthalmic slit lamp, surgical | | Class I Devices |
| Ophthalmic soft-tissue manipulation forceps, probe-like, reusable | | Ophthalmic soft-tissue manipulation forceps, probe-like, reusable | | Class I
|
| Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable | | Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable | | Class I
|
| Ophthalmic soft-tissue surgical forceps probe-tip, reusable | | Ophthalmic soft-tissue surgical forceps probe-tip, reusable | | Class I
|
| Ophthalmic sponge | | Ophthalmic sponge | | Class I
|
| Ophthalmic strabismus scissors | | Ophthalmic strabismus scissors | | Class I
|
| Ophthalmic surgery fluid collection bag | | Ophthalmic surgery fluid collection bag | | Class I Devices |
| Ophthalmic surgical device handling forceps | | Ophthalmic surgical device handling forceps | | Class I
|
| Ophthalmic surgical drape | | Ophthalmic surgical drape | | Class I
|
| Ophthalmic surgical dye | | Ophthalmic surgical dye | | Class I
|
| Ophthalmic surgical dye | | Ophthalmic surgical dye | | Class IIa
|
| Ophthalmic surgical dye | | Ophthalmic surgical dye | | Class IIb
|
| Ophthalmic surgical incision gauge | | Ophthalmic surgical incision gauge | | Class I
|
| Ophthalmic surgical instrument handle, manual | | Ophthalmic surgical instrument handle, manual | | Class I
|
| Ophthalmic surgical irrigation/infusion/aspiration handle, reusable | | Ophthalmic surgical irrigation/infusion/aspiration handle, reusable | | Class I
|
| Ophthalmic surgical irrigation/infusion/aspiration handle, reusable | | Ophthalmic surgical irrigation/infusion/aspiration handle, reusable | | Class IIa
|
| Ophthalmic surgical irrigation/infusion/aspiration handle, single-use | | Ophthalmic surgical irrigation/infusion/aspiration handle, single-use | | Class IIa
|
| Ophthalmic surgical procedure kit, non-medicated, reusable | | Ophthalmic surgical procedure kit, non-medicated, reusable | | Class I Devices |
| Ophthalmic surgical procedure kit, non-medicated, reusable | | Ophthalmic surgical procedure kit, non-medicated, reusable | |
|
| Ophthalmic surgical procedure kit, non-medicated, single-use | | Ophthalmic surgical procedure kit, non-medicated, single-use | | Class I Devices |
| Ophthalmic surgical procedure kit, non-medicated, single-use | | Ophthalmic surgical procedure kit, non-medicated, single-use | |
|
| Ophthalmic surgical procedure kit, non-medicated, single-use | | Ophthalmic surgical procedure kit, non-medicated, single-use | | Class I
|
| Ophthalmic Surgical Procedure Packs | | Ophthalmic Surgical Procedure Packs | |
|
| Ophthalmic suture scissors | | Ophthalmic suture scissors | | Class I
|
| Ophthalmic tenotomy scissors | | Ophthalmic tenotomy scissors | | Class I
|