Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Bone tunnel plug, cannulatedBone tunnel plug, cannulatedClass IIa
Bone tunnel plug, non-cannulatedBone tunnel plug, non-cannulatedClass IIa
Bone wax, naturalBone wax, naturalClass IIb
Bone wax, naturalBone wax, naturalClass III
Bone wax, syntheticBone wax, syntheticClass III
Bordetella pertussis immunoglobulin A (IgA) antibody IVD, controlBordetella pertussis immunoglobulin A (IgA) antibody IVD, controlIVD General
Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Bordetella pertussis immunoglobulin G (IgG) antibody IVD, controlBordetella pertussis immunoglobulin G (IgG) antibody IVD, controlIVD General
Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayBordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Bordetella pertussis nucleic acid IVD, controlBordetella pertussis nucleic acid IVD, controlIVD General
Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, controlBorrelia burgdorferi immunoglobulin G (IgG) antibody IVD, controlIVD General
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, reagentBorrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, reagentIVD General
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, controlBorrelia burgdorferi immunoglobulin M (IgM) antibody IVD, controlIVD General
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Borrelia burgdorferi nucleic acid IVD, controlBorrelia burgdorferi nucleic acid IVD, controlIVD General
Bouin's solution IVDBouin's solution IVDIVD General
Bovine serum albumin (BSA) immunohaematology reagent IVDBovine serum albumin (BSA) immunohaematology reagent IVDIVD General
Bowl/basin standBowl/basin standClass I
Brachytherapy needleBrachytherapy needle
Brachytherapy needleBrachytherapy needleClass IIa
Brachytherapy source spacerBrachytherapy source spacer
Brachytherapy system remote-afterloading operator consoleBrachytherapy system remote-afterloading operator console
Brachytherapy system remote-afterloading operator consoleBrachytherapy system remote-afterloading operator consoleClass IIb
Brachytherapy system remote afterloading source transfer tubeBrachytherapy system remote afterloading source transfer tube
Brachytherapy system remote afterloading source transfer tubeBrachytherapy system remote afterloading source transfer tubeClass I
Brachytherapy system remote afterloading source transfer tubeBrachytherapy system remote afterloading source transfer tubeClass IIa
Brachytherapy system remote afterloading source transfer tubeBrachytherapy system remote afterloading source transfer tubeClass IIb
BRAF gene mutation IVD, kit, nucleic acid sequencing techniqueBRAF gene mutation IVD, kit, nucleic acid sequencing techniqueIVD General
BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)IVD General
Brain-responsive electrical stimulation systemBrain-responsive electrical stimulation systemClass IIb
Brain biopsy procedure kitBrain biopsy procedure kit Conformity Assessment Certificate ExpiredClass III
Brain biopsy procedure kitBrain biopsy procedure kitClass IIa
Brain biopsy procedure kitBrain biopsy procedure kitClass III
Brain heart infusion (BHI)/Middlebrook 7H9 blood culture broth IVDBrain heart infusion (BHI)/Middlebrook 7H9 blood culture broth IVDIVD General
Brain knifeBrain knifeClass I
Brain spatulaBrain spatulaClass I
Brain spatulaBrain spatulaClass III
BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing techniqueBRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing techniqueIVD General
Breast binder, reusableBreast binder, reusableClass I
Breast ductography cannulaBreast ductography cannulaClass I
Breast implant delivery funnel, manualBreast implant delivery funnel, manualClass IIa
Breast implant delivery sleeveBreast implant delivery sleeveClass IIa
Breast pump support kit, reusableBreast pump support kit, reusableClass IIa
Breast pump support kit, single-use, sterileBreast pump support kit, single-use, sterileClass IIa
Breast pump, electricBreast pump, electricClass IIa
Breast ultrasound imaging systemBreast ultrasound imaging systemClass IIa
Breath ketone IVD, kit, colorimetric, rapidBreath ketone IVD, kit, colorimetric, rapidIVD General
Breath specimen container IVDBreath specimen container IVDIVD General
Breathing circuit bag, reusableBreathing circuit bag, reusableClass I
Breathing circuit bag, reusableBreathing circuit bag, reusableClass IIa
Breathing circuit bag, single-useBreathing circuit bag, single-use
Breathing circuit bag, single-useBreathing circuit bag, single-useClass I
Breathing circuit bag, single-useBreathing circuit bag, single-useClass IIa
Breathing circuit catheter mount, reusableBreathing circuit catheter mount, reusableClass IIa
Breathing circuit catheter mount, single-useBreathing circuit catheter mount, single-useClass I
Breathing circuit catheter mount, single-useBreathing circuit catheter mount, single-useClass IIa
Breathing circuit condensate trap, reusableBreathing circuit condensate trap, reusableClass IIa
Breathing circuit condensate trap, single-useBreathing circuit condensate trap, single-useClass I
Breathing circuit condensate trap, single-useBreathing circuit condensate trap, single-useClass IIa
Breathing circuit condenser cartridgeBreathing circuit condenser cartridgeClass IIa
Breathing circuit condenserBreathing circuit condenserClass IIa
Breathing circuit condenserBreathing circuit condenserClass III
Breathing circuit gas-flow sensor, reusableBreathing circuit gas-flow sensor, reusableClass IIa
Breathing circuit gas-flow sensor, reusableBreathing circuit gas-flow sensor, reusableClass IIb
Breathing circuit gas-flow sensor, single-useBreathing circuit gas-flow sensor, single-useClass IIa
Breathing circuit gas-sampling/monitoring setBreathing circuit gas-sampling/monitoring setClass IIa
Breathing circuit multi-parameter sensorBreathing circuit multi-parameter sensorClass IIa
Breathing circuit tube holderBreathing circuit tube holderClass I
Breathing mouthpiece, reusableBreathing mouthpiece, reusable
Breathing mouthpiece, reusableBreathing mouthpiece, reusableClass I
Breathing mouthpiece, reusableBreathing mouthpiece, reusableClass IIa
Breathing mouthpiece, single-useBreathing mouthpiece, single-useClass I
Breathing mouthpiece, single-useBreathing mouthpiece, single-useClass IIa
Bromelin immunohaematology reagent IVDBromelin immunohaematology reagent IVDIVD General
Bronchial balloon catheterBronchial balloon catheterClass IIa
Bronchial brachytherapy system applicator, remote-afterloadingBronchial brachytherapy system applicator, remote-afterloadingClass IIa
Bronchoscopic aspiration tube, rigidBronchoscopic aspiration tube, rigidClass I
Bronchoscopic biopsy curette, flexible, single-useBronchoscopic biopsy curette, flexible, single-useClass IIa
Bronchoscopic catheterBronchoscopic catheterClass IIa
Brucella abortus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayBrucella abortus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
Brucella abortus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayBrucella abortus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayIVD General
Brucella abortus total antibody IVD, controlBrucella abortus total antibody IVD, controlIVD General
Brucella abortus total antibody IVD, kit, agglutinationBrucella abortus total antibody IVD, kit, agglutinationIVD General
Brucella abortus total antibody IVD, reagentBrucella abortus total antibody IVD, reagentIVD General
Brucella melitensis total antibody IVD, kit, agglutinationBrucella melitensis total antibody IVD, kit, agglutinationIVD General
BSI Basic StandBSI Basic StandClass I
Bucket linerBucket linerClass I
Buffered isotonic saline reagent IVDBuffered isotonic saline reagent IVDIVD General
Buffered sample diluent IVD, automated/semi-automated systemBuffered sample diluent IVD, automated/semi-automated systemIVD General
Buffered sample diluent IVD, manualBuffered sample diluent IVD, manualIVD General
Buffered wash solution IVD, automated/semi-automated systemBuffered wash solution IVD, automated/semi-automated systemIVD General
Buffered wash solution IVD, manualBuffered wash solution IVD, manualIVD General
Bulk oxygen concentration systemBulk oxygen concentration systemClass IIa
Bunion shieldBunion shield
Bunion shieldBunion shieldClass I
Bunsen burnerBunsen burner
Buprenorphine IVD, controlBuprenorphine IVD, controlIVD General
Buprenorphine IVD, kit, enzyme immunoassay (EIA)Buprenorphine IVD, kit, enzyme immunoassay (EIA)IVD General
Buprenorphine IVD, kit, immunochromatographic test (ICT), rapidBuprenorphine IVD, kit, immunochromatographic test (ICT), rapidIVD General
Burn bathBurn bath Conformity Assessment Certificate ExpiredClass I
Burn gelBurn gelClass IIa
Burn gelBurn gelClass IIb
Burn gel, non-sterileBurn gel, non-sterile Conformity Assessment Certificate ExpiredClass IIa
Burn gel, non-sterileBurn gel, non-sterileClass IIa
Burn gel, non-sterileBurn gel, non-sterileClass IIb
Burn kit, non-medicatedBurn kit, non-medicated
Burns AssessmentBurns AssessmentClass I
Burring power tool attachmentBurring power tool attachmentClass IIa
C-erbB2/Her2/neu oncoprotein IVD, antibodyC-erbB2/Her2/neu oncoprotein IVD, antibodyIVD General
C-erbB2/Her2/neu oncoprotein IVD, controlC-erbB2/Her2/neu oncoprotein IVD, controlIVD General
C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistryC-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistryIVD General
C-peptide IVD, calibratorC-peptide IVD, calibratorIVD General
C-peptide IVD, controlC-peptide IVD, controlIVD General
C-peptide IVD, kit, chemiluminescent immunoassayC-peptide IVD, kit, chemiluminescent immunoassayIVD General
C-peptide IVD, kit, radioimmunoassayC-peptide IVD, kit, radioimmunoassayIVD General
C-reactive protein (CRP) IVD, controlC-reactive protein (CRP) IVD, controlIVD General
C-reactive protein (CRP) IVD, kit, agglutination, rapidC-reactive protein (CRP) IVD, kit, agglutination, rapidIVD General
C-reactive protein (CRP) IVD, kit, fluorescent immunoassayC-reactive protein (CRP) IVD, kit, fluorescent immunoassayIVD General
C-reactive protein (CRP) IVD, kit, immunochromatographic test (ICT)C-reactive protein (CRP) IVD, kit, immunochromatographic test (ICT)IVD General
C-reactive protein (CRP) IVD, kit, immunochromatographic test (ICT), self-testingC-reactive protein (CRP) IVD, kit, immunochromatographic test (ICT), self-testingIVD Devices for Self-Testing
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetryC-reactive protein (CRP) IVD, kit, nephelometry/turbidimetryIVD General
C-reactive protein (CRP) IVD, reagentC-reactive protein (CRP) IVD, reagentIVD General
Cable/lead holderCable/lead holder
Cable/lead holderCable/lead holderClass I
Cable/lead holderCable/lead holderClass IIa
Cable/lead/sensor/probe cover, non-sterileCable/lead/sensor/probe cover, non-sterileClass I
Cadherin protein IVD, antibodyCadherin protein IVD, antibodyIVD General
CAD/CAM softwareCAD/CAM software
CAD/CAM softwareCAD/CAM softwareClass I
CAD/CAM softwareCAD/CAM softwareClass IIa
Caecostomy tubeCaecostomy tubeClass IIb
Calcitonin IVD, antibodyCalcitonin IVD, antibodyIVD General
Calcium chloride coagulation reagent IVDCalcium chloride coagulation reagent IVDIVD General
Calcium hydroxide dental cementCalcium hydroxide dental cementClass IIa
Calcium hydroxide dental suspensionCalcium hydroxide dental suspensionClass IIa
Calcium (Ca2+) electrode IVDCalcium (Ca2+) electrode IVDIVD General
Calcium (Ca2+) IVD, kit, spectrophotometryCalcium (Ca2+) IVD, kit, spectrophotometryIVD General
Calculator, programmableCalculator, programmable
Calf implantCalf implant Conformity Assessment Certificate ExpiredClass IIb
Calf implantCalf implantClass IIb
Calf/shin orthosisCalf/shin orthosisClass I
Calibration gas cylinder regulatorCalibration gas cylinder regulatorClass IIb
Calibration gas/non-refillable cylinderCalibration gas/non-refillable cylinderClass I
Callous file/rasp, reusableCallous file/rasp, reusableClass I
Calponin protein IVD, antibodyCalponin protein IVD, antibodyIVD General
Calprotectin IVD, kit, enzyme immunoassay (EIA)Calprotectin IVD, kit, enzyme immunoassay (EIA)IVD General
Calprotectin IVD, kit, immunochromatographic test (ICT), rapidCalprotectin IVD, kit, immunochromatographic test (ICT), rapidIVD General
Calreticulin (CALR) gene mutation IVD, kit, nucleic acid technique (NAT)Calreticulin (CALR) gene mutation IVD, kit, nucleic acid technique (NAT)IVD General
Calretinin protein IVD, antibodyCalretinin protein IVD, antibodyIVD General
Camera application softwareCamera application softwareClass I
Campylobacter fetus antibody IVD, controlCampylobacter fetus antibody IVD, controlIVD General
Campylobacter fetus antibody IVD, reagentCampylobacter fetus antibody IVD, reagentIVD General
Campylobacter jejuni antibody IVD, controlCampylobacter jejuni antibody IVD, controlIVD General
Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)IVD General
Campylobacter jejuni antibody IVD, reagentCampylobacter jejuni antibody IVD, reagentIVD General
Canalith repositioning procedure chair, manualCanalith repositioning procedure chair, manualClass IIa
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)IVD General
Cancer antigen 125 (CA125) IVD, antibodyCancer antigen 125 (CA125) IVD, antibodyIVD General
Cancer antigen 125 (CA125) IVD, calibratorCancer antigen 125 (CA125) IVD, calibratorIVD General
Cancer antigen 125 (CA125) IVD, controlCancer antigen 125 (CA125) IVD, controlIVD General
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayCancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayIVD General
Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)IVD General
Cancer antigen 125 (CA125) IVD, kit, immunochromatographic test (ICT), rapidCancer antigen 125 (CA125) IVD, kit, immunochromatographic test (ICT), rapidIVD General
Cancer antigen 125 (CA125) IVD, kit, radioimmunoassayCancer antigen 125 (CA125) IVD, kit, radioimmunoassayIVD General
Cancer antigen 15-3 (CA15-3) IVD, calibratorCancer antigen 15-3 (CA15-3) IVD, calibratorIVD General
Cancer antigen 15-3 (CA15-3) IVD, controlCancer antigen 15-3 (CA15-3) IVD, controlIVD General
Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassayCancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassayIVD General
Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)IVD General
Cancer antigen 15-3 (CA15-3) IVD, kit, immunochromatographic test (ICT), rapidCancer antigen 15-3 (CA15-3) IVD, kit, immunochromatographic test (ICT), rapidIVD General
Cancer antigen 15-3 (CA15-3) IVD, kit, radioimmunoassayCancer antigen 15-3 (CA15-3) IVD, kit, radioimmunoassayIVD General
Cancer antigen 19-9 (CA19-9) GI IVD, antibodyCancer antigen 19-9 (CA19-9) GI IVD, antibodyIVD General
Cancer antigen 19-9 (CA19-9) IVD, calibratorCancer antigen 19-9 (CA19-9) IVD, calibratorIVD General
Cancer antigen 19-9 (CA19-9) IVD, controlCancer antigen 19-9 (CA19-9) IVD, controlIVD General
Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)IVD General
Cancer antigen 19-9 (CA19-9) IVD, kit, immunochromatographic test (ICT), rapidCancer antigen 19-9 (CA19-9) IVD, kit, immunochromatographic test (ICT), rapidIVD General
Cancer antigen 19-9 (CA19-9) IVD, kit, radioimmunoassayCancer antigen 19-9 (CA19-9) IVD, kit, radioimmunoassayIVD General
Cancer antigen 72-4 (CA 72-4) IVD, kit, chemiluminescent immunoassayCancer antigen 72-4 (CA 72-4) IVD, kit, chemiluminescent immunoassayIVD General
Cancer antigen 72-4 (CA72-4) IVD, calibratorCancer antigen 72-4 (CA72-4) IVD, calibratorIVD General
Cancer antigen 72-4 (CA72-4) IVD, controlCancer antigen 72-4 (CA72-4) IVD, controlIVD General
Cancer risk assessment interpretive softwareCancer risk assessment interpretive softwareIVD General
Cancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassayCancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassayIVD General
Candida albicans antigen IVD, reagentCandida albicans antigen IVD, reagentIVD General
Candida albicans immunoglobulin A (IgA) antibody IVD, controlCandida albicans immunoglobulin A (IgA) antibody IVD, controlIVD General
Candida albicans immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)Candida albicans immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Candida albicans immunoglobulin G (IgG) antibody IVD, controlCandida albicans immunoglobulin G (IgG) antibody IVD, controlIVD General
Candida albicans immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayCandida albicans immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Candida albicans immunoglobulin M (IgM) antibody IVD, controlCandida albicans immunoglobulin M (IgM) antibody IVD, controlIVD General
Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Candida albicans nucleic acid IVD, kit, nucleic acid technique (NAT)Candida albicans nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA)Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA)IVD General
Cannabinoid IVD, controlCannabinoid IVD, controlIVD General
Cannabinoid IVD, kit, immunochromatographic test (ICT), rapidCannabinoid IVD, kit, immunochromatographic test (ICT), rapidIVD General
Cannula clampCannula clampClass I
Cannulae (Reusable)Cannulae (Reusable)Class I