Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Invasive medical device leak tester mechanicalInvasive medical device leak tester mechanical
Invasive medical device leak tester mechanicalInvasive medical device leak tester mechanicalClass I
Invasive ultrasound transducer cooling/coupling support kitInvasive ultrasound transducer cooling/coupling support kitClass IIa
Invasive vascular ultrasound system probeInvasive vascular ultrasound system probe
Invasive vascular ultrasound system probeInvasive vascular ultrasound system probeClass IIa
Invasive vascular ultrasound system probeInvasive vascular ultrasound system probeClass III
Invasive vascular ultrasound systemInvasive vascular ultrasound system
Invasive vascular ultrasound systemInvasive vascular ultrasound systemClass IIa
Invasive/noninvasive vascular ultrasound probeInvasive/noninvasive vascular ultrasound probe
Invasive/noninvasive vascular ultrasound probeInvasive/noninvasive vascular ultrasound probeClass IIa
Invasive/noninvasive vascular ultrasound probeInvasive/noninvasive vascular ultrasound probeClass III
Inverted-stage light microscopeInverted-stage light microscopeClass I
Ion-selective analyser IVD semi-automatedIon-selective analyser IVD semi-automatedClass A
Ion-selective analyser IVD semi-automatedIon-selective analyser IVD semi-automatedIVD General
Ion-selective analyser IVDIon-selective analyser IVDIVD General
Ion selective electrode (ISE) reference solution IVD reagentIon selective electrode (ISE) reference solution IVD reagentClass A
Ion selective electrode (ISE) reference solution IVD reagentIon selective electrode (ISE) reference solution IVD reagentIVD General
Ionization-chamber radiation survey meterIonization-chamber radiation survey meterClass I
Ionization chamber radiation measuring probeIonization chamber radiation measuring probeClass IIb
Iontophoresis system electrode returnIontophoresis system electrode returnClass IIa
Iron IVD calibratorIron IVD calibratorIVD General
Iron IVD controlIron IVD controlIVD General
Iron IVD kit enzyme spectrophotometryIron IVD kit enzyme spectrophotometryClass B
Iron IVD kit enzyme spectrophotometryIron IVD kit enzyme spectrophotometryIVD General
Iron IVD kit spectrophotometryIron IVD kit spectrophotometryIVD General
Iron IVD reagentIron IVD reagentIVD General
Irreversible electroporation system bronchoscopic catheterIrreversible electroporation system bronchoscopic catheterClass IIa
Irreversible electroporation system generatorIrreversible electroporation system generator
Irreversible electroporation system generatorIrreversible electroporation system generatorClass IIb
Irreversible electroporation system probe spacerIrreversible electroporation system probe spacerClass I
Irreversible electroporation systemIrreversible electroporation systemClass IIb
Irrigation negative-pressure wound therapy dressingIrrigation negative-pressure wound therapy dressingClass IIb
Irrigation negative-pressure wound therapy unitIrrigation negative-pressure wound therapy unitClass IIa
Irrigation solution pressure infusorIrrigation solution pressure infusorClass I
Irrigation solution pressure infusorIrrigation solution pressure infusorClass IIa
Irrigation syringeIrrigation syringeClass I
Irrigation syringeIrrigation syringeClass IIa
Islet cell antibody 512 (anti-ICA512) IVD kit enzyme immunoassay (EIA)Islet cell antibody 512 (anti-ICA512) IVD kit enzyme immunoassay (EIA)IVD General
Islet cell antibody IVD controlIslet cell antibody IVD controlIVD General
Islet cell antibody IVD kit chemiluminescent immunoassayIslet cell antibody IVD kit chemiluminescent immunoassayIVD General
Islet cell antibody IVD kit fluorescent immunoassayIslet cell antibody IVD kit fluorescent immunoassayIVD General
Islet cell antibody IVD reagentIslet cell antibody IVD reagentIVD General
Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD controlIsocitrate dehydrogenase 1 (IDH1) gene mutation IVD controlIVD General
Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD kit nucleic acid technique (NAT)Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD kit nucleic acid technique (NAT)IVD General
Isocitrate dehydrogenase 1 (IDH1) IVD antibodyIsocitrate dehydrogenase 1 (IDH1) IVD antibodyIVD General
Isocitrate dehydrogenase 1/isocitrate dehydrogenase 2 (IDH1/IDH2) gene mutation IVD kit nucleic acid technique (NAT)Isocitrate dehydrogenase 1/isocitrate dehydrogenase 2 (IDH1/IDH2) gene mutation IVD kit nucleic acid technique (NAT)IVD General
Isoflurane anaesthesia vaporizerIsoflurane anaesthesia vaporizerClass IIb
Isoflurane/sevoflurane recycling anaesthesia vaporizerIsoflurane/sevoflurane recycling anaesthesia vaporizer
Isoflurane/sevoflurane recycling anaesthesia vaporizerIsoflurane/sevoflurane recycling anaesthesia vaporizerClass IIa
Isolation gown reusableIsolation gown reusableClass I
Isolation gown single-useIsolation gown single-use Conformity Assessment Certificate ExpiredClass I
Isolation gown single-useIsolation gown single-useClass I
Isolation Media (Plates)Isolation Media (Plates)IVD General
Isolation transformerIsolation transformerClass I
Isopropanol alcohol IVD reagentIsopropanol alcohol IVD reagentIVD General
Isothermal nucleic acid amplification analyser IVD laboratory automatedIsothermal nucleic acid amplification analyser IVD laboratory automatedIVD General
Isothermal nucleic acid amplification analyser IVD laboratoryIsothermal nucleic acid amplification analyser IVD laboratoryClass A
Isothermal nucleic acid amplification analyser IVD laboratoryIsothermal nucleic acid amplification analyser IVD laboratoryIVD General
Isothermal nucleic acid amplification analyser IVD point-of-careIsothermal nucleic acid amplification analyser IVD point-of-careIVD General
Isotonic saline reagent IVDIsotonic saline reagent IVDClass A
Isotonic saline reagent IVDIsotonic saline reagent IVDIVD General
Itraconazole susceptibility testing disc IVDItraconazole susceptibility testing disc IVDIVD General
IVD Thread RetrieverIVD Thread RetrieverClass I
IVF medium kitIVF medium kit
IVF medium kitIVF medium kitClass IIa
IVF medium kitIVF medium kitClass IIb
IVF medium kitIVF medium kitClass III
IVF mediumIVF medium
IVF mediumIVF mediumClass IIa
IVF mediumIVF mediumClass IIb
IVF mediumIVF mediumClass III
IVF oocyte aspiration needle single-useIVF oocyte aspiration needle single-use Conformity Assessment Certificate ExpiredClass IIa
IVF oocyte aspiration needle single-useIVF oocyte aspiration needle single-useClass IIa
IVF oocyte aspiration pumpIVF oocyte aspiration pumpClass IIa
JAK2 V617F gene mutation IVD kit nucleic acid technique (NAT)JAK2 V617F gene mutation IVD kit nucleic acid technique (NAT)Class C
JAK2 V617F gene mutation IVD kit nucleic acid technique (NAT)JAK2 V617F gene mutation IVD kit nucleic acid technique (NAT)IVD General
Japanese encephalitis (JE) virus nucleic acid IVD kit nucleic acid technique (NAT)Japanese encephalitis (JE) virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Jaw physiology evaluation systemJaw physiology evaluation systemClass I
JC virus (JCV) antigen IVD kit enzyme immunoassay (EIA)JC virus (JCV) antigen IVD kit enzyme immunoassay (EIA)IVD General
JC virus (JCV) antigen IVD reagentJC virus (JCV) antigen IVD reagentIVD General
JC virus (JCV) nucleic acid IVD controlJC virus (JCV) nucleic acid IVD controlIVD General
JC virus (JCV) nucleic acid IVD kit nucleic acid technique (NAT)JC virus (JCV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
JC virus (JCV) nucleic acid IVD reagentJC virus (JCV) nucleic acid IVD reagentIVD General
Jejunostomy tubeJejunostomy tubeClass I
Jejunostomy tubeJejunostomy tubeClass IIa
Jejunostomy tubeJejunostomy tubeClass IIb
Jo-1 antibody IVD calibratorJo-1 antibody IVD calibratorIVD General
Jo-1 antibody IVD controlJo-1 antibody IVD controlIVD General
Jo-1 antibody IVD kit chemiluminescent immunoassayJo-1 antibody IVD kit chemiluminescent immunoassayIVD General
Jo-1 antibody IVD kit enzyme immunoassay (EIA)Jo-1 antibody IVD kit enzyme immunoassay (EIA)IVD General
Jo-1 antibody IVD kit fluorescent immunoassayJo-1 antibody IVD kit fluorescent immunoassayIVD General
Jo-1 antibody kitJo-1 antibody kitIVD General
Joint injection needleJoint injection needleClass IIa
Joint lubrication gelJoint lubrication gelClass I
Joint lubrication gelJoint lubrication gelClass III
Joint prosthesis implantation kit reusableJoint prosthesis implantation kit reusable
Joint prosthesis implantation kit reusableJoint prosthesis implantation kit reusableClass I
Joint prosthesis implantation kit reusableJoint prosthesis implantation kit reusableClass IIa
Joint prosthesis implantation kit single-useJoint prosthesis implantation kit single-use
Joint prosthesis implantation kit single-useJoint prosthesis implantation kit single-useClass I
Joint prosthesis implantation kit single-useJoint prosthesis implantation kit single-useClass IIa
Joint/spinal manipulator mechanicalJoint/spinal manipulator mechanicalClass I
Kallmann syndrome IVD probeKallmann syndrome IVD probeIVD General
Kanamycin susceptibility testing disc IVDKanamycin susceptibility testing disc IVDIVD General
Kappa/lambda light chain immunoglobulin IVD antibodyKappa/lambda light chain immunoglobulin IVD antibodyClass C
Kappa/lambda light chain immunoglobulin IVD antibodyKappa/lambda light chain immunoglobulin IVD antibodyIVD General
Kappa/lambda light chain immunoglobulin IVD calibratorKappa/lambda light chain immunoglobulin IVD calibratorIVD General
Kappa/lambda light chain immunoglobulin IVD controlKappa/lambda light chain immunoglobulin IVD controlIVD General
Kappa/lambda light chain immunoglobulin IVD kit enzyme immunoassay (EIA)Kappa/lambda light chain immunoglobulin IVD kit enzyme immunoassay (EIA)IVD General
Kappa/lambda light chain immunoglobulin IVD kit enzyme immunohistochemistryKappa/lambda light chain immunoglobulin IVD kit enzyme immunohistochemistryIVD General
Kappa/lambda light chain immunoglobulin IVD kit nephelometry/turbidimetryKappa/lambda light chain immunoglobulin IVD kit nephelometry/turbidimetryIVD General
Kappa/lambda light chain immunoglobulin IVD kit rapid ICT clinicalKappa/lambda light chain immunoglobulin IVD kit rapid ICT clinicalIVD General
Kappa/lambda light chain immunoglobulin IVD reagentKappa/lambda light chain immunoglobulin IVD reagentIVD General
Kappa/lambda light chain messenger RNA IVD controlKappa/lambda light chain messenger RNA IVD controlClass C
Kappa/lambda light chain messenger RNA IVD controlKappa/lambda light chain messenger RNA IVD controlIVD General
Kappa/lambda light chain messenger RNA IVD probeKappa/lambda light chain messenger RNA IVD probeIVD General
Keratolytic solutionKeratolytic solutionClass IIa
Keratome blade single-useKeratome blade single-useClass I
Keratome blade single-useKeratome blade single-useClass IIa
Keratoscope non-powered reusableKeratoscope non-powered reusableClass I
Keratoscope poweredKeratoscope poweredClass IIa
Ketamine/ketamine metabolite IVD calibratorKetamine/ketamine metabolite IVD calibratorIVD General
Ketamine/ketamine metabolite IVD controlKetamine/ketamine metabolite IVD controlIVD General
Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA)Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Ketamine/ketamine metabolite IVD reagentKetamine/ketamine metabolite IVD reagentIVD General
Ketoconazole susceptibility testing disc IVDKetoconazole susceptibility testing disc IVDIVD General
Ketone (acetoacetate) IVD controlKetone (acetoacetate) IVD controlIVD Devices for Self-Testing
Ketone (acetoacetate) IVD controlKetone (acetoacetate) IVD controlIVD General
Ketone (acetoacetate) IVD kit rapid colorimetric clinicalKetone (acetoacetate) IVD kit rapid colorimetric clinicalIVD General
Ketone (acetoacetate) IVD reagentKetone (acetoacetate) IVD reagentIVD Devices for Self-Testing
Ketone (acetoacetate) IVD reagentKetone (acetoacetate) IVD reagentIVD General
Ki67 antigen IVD antibodyKi67 antigen IVD antibodyIVD General
Ki67 antigen IVD kit enzyme immunohistochemistryKi67 antigen IVD kit enzyme immunohistochemistryIVD General
Kick bucketKick bucketClass I
Kidd (Jk^a & Jk^b) multiple blood grouping IVD kit agglutinationKidd (Jk^a & Jk^b) multiple blood grouping IVD kit agglutinationIVD Annex II List B
Kidney donor-organ preservation/transport perfusion setKidney donor-organ preservation/transport perfusion setClass I
Kidney donor-organ preservation/transport perfusion setKidney donor-organ preservation/transport perfusion setClass IIa
Kidney donor-organ preservation/transport systemKidney donor-organ preservation/transport systemClass IIa
Kidney donor-organ preservation/transport systemKidney donor-organ preservation/transport systemClass IIb
Kinesiology ambulatory recorderKinesiology ambulatory recorderClass I
Kinesiology/electromyographic sensor setKinesiology/electromyographic sensor setClass I
Kinesiology/electromyographic sensor setKinesiology/electromyographic sensor setClass IIa
Kinetic bedKinetic bedClass I
KIT gene mutation IVD kit nucleic acid technique (NAT)KIT gene mutation IVD kit nucleic acid technique (NAT)IVD General
Kligler-iron Enterobacteriaceae agar culture medium IVDKligler-iron Enterobacteriaceae agar culture medium IVDIVD General
Knee-disarticulation prosthesisKnee-disarticulation prosthesis
Knee arthrodesis prosthesisKnee arthrodesis prosthesis
Knee arthrodesis prosthesisKnee arthrodesis prosthesisClass IIa
Knee arthrodesis prosthesisKnee arthrodesis prosthesisClass IIb
Knee arthroplasty force sensor balance kitKnee arthroplasty force sensor balance kitClass I
Knee arthroplasty wedgeKnee arthroplasty wedge Conformity Assessment Certificate ExpiredClass III
Knee arthroplasty wedgeKnee arthroplasty wedge
Knee arthroplasty wedgeKnee arthroplasty wedgeClass IIb
Knee arthroplasty wedgeKnee arthroplasty wedgeClass III
Knee distraction orthosisKnee distraction orthosisClass I
Knee femur prosthesis trial reusableKnee femur prosthesis trial reusable
Knee femur prosthesis trial reusableKnee femur prosthesis trial reusableClass I
Knee femur prosthesis trial reusableKnee femur prosthesis trial reusableClass IIa
Knee femur prosthesis trial reusableKnee femur prosthesis trial reusableClass III
Knee femur stem prosthesisKnee femur stem prosthesis Conformity Assessment Certificate ExpiredClass III
Knee femur stem prosthesisKnee femur stem prosthesis
Knee femur stem prosthesisKnee femur stem prosthesisClass IIb
Knee femur stem prosthesisKnee femur stem prosthesisClass III
Knee femur stem/sleeve connectorKnee femur stem/sleeve connector Conformity Assessment Certificate ExpiredClass III
Knee femur stem/sleeve connectorKnee femur stem/sleeve connector
Knee immobilizerKnee immobilizerClass I
Knee revision prosthesis trialKnee revision prosthesis trial
Knee revision prosthesis trialKnee revision prosthesis trialClass IIa
Knee stem prosthesis trialKnee stem prosthesis trialClass IIa
Knee support orthosisKnee support orthosis
Knee support orthosisKnee support orthosisClass I
Knee support/thermal therapy bandageKnee support/thermal therapy bandageClass I
Knee tibia prosthesis plugKnee tibia prosthesis plug Conformity Assessment Certificate ExpiredClass III
Knee tibia prosthesis plugKnee tibia prosthesis plug
Knee tibia prosthesis plugKnee tibia prosthesis plugClass IIb
Knee tibia prosthesis plugKnee tibia prosthesis plugClass III
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusable
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusableClass I
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusableClass IIa
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusableClass III
Knee/ankle/foot orthosisKnee/ankle/foot orthosis
Knee/ankle/foot orthosisKnee/ankle/foot orthosisClass I
KRAS gene mutation IVD kit nucleic acid sequencing techniqueKRAS gene mutation IVD kit nucleic acid sequencing techniqueIVD General
KRAS gene mutation IVD kit nucleic acid technique (NAT)KRAS gene mutation IVD kit nucleic acid technique (NAT)IVD General
Ku antibody (anti-Ku) IVD controlKu antibody (anti-Ku) IVD controlIVD General
Kynurenine IVD kit enzyme immunoassay (EIA)Kynurenine IVD kit enzyme immunoassay (EIA)IVD General
Kyphoplasty balloon catheterKyphoplasty balloon catheterClass IIa
L523S protein IVD antibodyL523S protein IVD antibodyIVD General
Laboratory analyser cuvette IVD reusableLaboratory analyser cuvette IVD reusableClass A
Laboratory analyser cuvette IVD reusableLaboratory analyser cuvette IVD reusableIVD General
Laboratory analyser cuvette IVD single-useLaboratory analyser cuvette IVD single-useClass A
Laboratory analyser cuvette IVD single-useLaboratory analyser cuvette IVD single-useIVD General
Laboratory analyser operation system software IVDLaboratory analyser operation system software IVDClass A
Laboratory analyser operation system software IVDLaboratory analyser operation system software IVDIVD General
Laboratory analyser/instrument absorbent liner IVDLaboratory analyser/instrument absorbent liner IVDClass A
Laboratory container robotic transfer system IVD semi-automatedLaboratory container robotic transfer system IVD semi-automatedIVD General
Laboratory container/microscope slide robotic transfer system IVDLaboratory container/microscope slide robotic transfer system IVDClass A
Laboratory container/microscope slide robotic transfer system IVDLaboratory container/microscope slide robotic transfer system IVDIVD General
Laboratory instrument application software IVDLaboratory instrument application software IVDIVD General
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDClass A