Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Brucella melitensis total antibody IVD kit agglutinationBrucella melitensis total antibody IVD kit agglutinationIVD General
Brucella species agar culture medium IVDBrucella species agar culture medium IVDIVD General
Bucket linerBucket linerClass I
Buffered isotonic saline reagent IVDBuffered isotonic saline reagent IVDClass A
Buffered isotonic saline reagent IVDBuffered isotonic saline reagent IVDIVD Annex II List B
Buffered isotonic saline reagent IVDBuffered isotonic saline reagent IVDIVD General
Buffered peptone water Salmonella species broth culture medium IVDBuffered peptone water Salmonella species broth culture medium IVDIVD General
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemClass A
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemIVD Annex II List A
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualClass A
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemClass A
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemIVD General
Buffered wash solution IVD manualBuffered wash solution IVD manualClass A
Buffered wash solution IVD manualBuffered wash solution IVD manualIVD General
Bulk oxygen concentration systemBulk oxygen concentration systemClass IIa
Bullous pemphigoid antigen 1 (BPAG1) antibody IVD kit enzyme immunoassay (EIA)Bullous pemphigoid antigen 1 (BPAG1) antibody IVD kit enzyme immunoassay (EIA)IVD General
Bullous pemphigoid antigen 2 (BPAG2) antibody IVD kit enzyme immunoassay (EIA)Bullous pemphigoid antigen 2 (BPAG2) antibody IVD kit enzyme immunoassay (EIA)IVD General
Bunion shieldBunion shield
Bunion shieldBunion shieldClass I
Buprenorphine IVD calibratorBuprenorphine IVD calibratorIVD General
Buprenorphine IVD controlBuprenorphine IVD controlIVD General
Buprenorphine IVD kit enzyme immunoassay (EIA)Buprenorphine IVD kit enzyme immunoassay (EIA)IVD General
Buprenorphine IVD kit rapid ICT clinicalBuprenorphine IVD kit rapid ICT clinicalIVD General
Burn bathBurn bathClass I
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 gelBurn gelClass IIa
Burn gelBurn gelClass IIb
Burn kit medicatedBurn kit medicated
Burn kit non-medicatedBurn kit non-medicated
Burn kit non-medicatedBurn kit non-medicatedClass IIb
Burring power tool attachmentBurring power tool attachment Conformity Assessment Certificate ExpiredClass IIa
Burring power tool attachmentBurring power tool attachmentClass I
Burring power tool attachmentBurring power tool attachmentClass IIa
Busulfan therapeutic drug monitoring IVD calibratorBusulfan therapeutic drug monitoring IVD calibratorIVD General
Busulfan therapeutic drug monitoring IVD controlBusulfan therapeutic drug monitoring IVD controlIVD General
Busulfan therapeutic drug monitoring IVD reagentBusulfan therapeutic drug monitoring IVD reagentIVD General
Butterfly skin-closure adhesive stripButterfly skin-closure adhesive stripClass I
Butzler Campylobacter species agar culture medium IVDButzler Campylobacter species agar culture medium IVDIVD General
C-erbB2/Her2/neu oncoprotein IVD antibodyC-erbB2/Her2/neu oncoprotein IVD antibodyIVD General
C-erbB2/Her2/neu oncoprotein IVD calibratorC-erbB2/Her2/neu oncoprotein IVD calibratorIVD General
C-erbB2/Her2/neu oncoprotein IVD controlC-erbB2/Her2/neu oncoprotein IVD controlClass C
C-erbB2/Her2/neu oncoprotein IVD controlC-erbB2/Her2/neu oncoprotein IVD controlIVD General
C-erbB2/Her2/neu oncoprotein IVD kit chemiluminescent immunoassayC-erbB2/Her2/neu oncoprotein IVD kit chemiluminescent immunoassayIVD General
C-erbB2/Her2/neu oncoprotein IVD kit enzyme immunohistochemistryC-erbB2/Her2/neu oncoprotein IVD kit enzyme immunohistochemistryIVD General
C-erbB2/Her2/neu oncoprotein IVD reagentC-erbB2/Her2/neu oncoprotein IVD reagentIVD General
c-MYC proto-oncogene protein IVD antibodyc-MYC proto-oncogene protein IVD antibodyClass C
c-MYC proto-oncogene protein IVD antibodyc-MYC proto-oncogene protein IVD antibodyIVD General
C-peptide IVD calibratorC-peptide IVD calibratorClass B
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 immunoassayClass B
C-peptide IVD kit chemiluminescent immunoassayC-peptide IVD kit chemiluminescent immunoassayIVD General
C-peptide IVD kit enzyme immunoassay (EIA)C-peptide IVD kit enzyme immunoassay (EIA)IVD General
C-peptide IVD kit radioimmunoassayC-peptide IVD kit radioimmunoassayIVD General
C-peptide IVD kit rapid ICT clinicalC-peptide IVD kit rapid ICT clinicalIVD General
C-peptide IVD reagentC-peptide IVD reagentIVD General
C-reactive protein (CRP) IVD antibodyC-reactive protein (CRP) IVD antibodyIVD General
C-reactive protein (CRP) IVD calibratorC-reactive protein (CRP) IVD calibratorIVD 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 chemiluminescent immunoassayC-reactive protein (CRP) IVD kit chemiluminescent immunoassayIVD General
C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA)C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA)IVD General
C-reactive protein (CRP) IVD kit enzyme spectrophotometryC-reactive protein (CRP) IVD kit enzyme spectrophotometryIVD General
C-reactive protein (CRP) IVD kit fluorescent immunoassayC-reactive protein (CRP) IVD kit fluorescent immunoassayIVD General
C-reactive protein (CRP) IVD kit nephelometry/turbidimetryC-reactive protein (CRP) IVD kit nephelometry/turbidimetryIVD General
C-reactive protein (CRP) IVD kit precipitation/immunodiffusionC-reactive protein (CRP) IVD kit precipitation/immunodiffusionIVD General
C-reactive protein (CRP) IVD kit rapid ICT clinicalC-reactive protein (CRP) IVD kit rapid ICT clinicalIVD General
C-reactive protein (CRP) IVD kit rapid ICT self-testingC-reactive protein (CRP) IVD kit rapid ICT self-testingIVD Devices for Self-Testing
C-reactive protein (CRP) IVD reagentC-reactive protein (CRP) IVD reagentIVD General
C-X-C motif chemokine ligand 13 (CXCL13) IVD kit rapid ICT clinicalC-X-C motif chemokine ligand 13 (CXCL13) IVD kit rapid ICT clinicalIVD General
Cable/lead holderCable/lead holder
Cable/lead holderCable/lead holderClass I
Cable/lead holderCable/lead holderClass IIa
Cable/lead holderCable/lead holderClass III
Cadherin protein IVD antibodyCadherin protein IVD antibodyClass C
Cadherin protein IVD antibodyCadherin protein IVD antibodyIVD General
Cadmium IVD kit mass spectrometryCadmium IVD kit mass spectrometryIVD General
CAD/CAM softwareCAD/CAM software
CAD/CAM softwareCAD/CAM softwareClass I
CAD/CAM softwareCAD/CAM softwareClass IIa
CAD/CAM softwareCAD/CAM softwareClass IIb
Caecostomy tubeCaecostomy tubeClass I
Caecostomy tubeCaecostomy tubeClass IIb
Caffeine IVD controlCaffeine IVD controlIVD General
Caffeine IVD kit enzyme immunoassay (EIA)Caffeine IVD kit enzyme immunoassay (EIA)IVD General
Caffeine IVD reagentCaffeine IVD reagentIVD General
Calcitonin IVD antibodyCalcitonin IVD antibodyIVD General
Calcitonin IVD calibratorCalcitonin IVD calibratorIVD General
Calcitonin IVD controlCalcitonin IVD controlIVD General
Calcitonin IVD kit chemiluminescent immunoassayCalcitonin IVD kit chemiluminescent immunoassayIVD General
Calcitonin IVD kit enzyme immunohistochemistryCalcitonin IVD kit enzyme immunohistochemistryIVD General
Calcitonin IVD kit radioimmunoassayCalcitonin IVD kit radioimmunoassayIVD General
Calcitonin IVD reagentCalcitonin IVD reagentIVD General
Calcium chloride coagulation reagent IVDCalcium chloride coagulation reagent IVDClass A
Calcium chloride coagulation reagent IVDCalcium chloride coagulation reagent IVDIVD General
Calcium hydroxide dental cementCalcium hydroxide dental cementClass IIa
Calcium hydroxide dental cementCalcium hydroxide dental cementClass IIb
Calcium hydroxide dental suspensionCalcium hydroxide dental suspensionClass IIa
Calcium (Ca2+) electrode IVDCalcium (Ca2+) electrode IVDIVD General
Calcium (Ca2+) IVD kit ion-selective electrode (ISE)Calcium (Ca2+) IVD kit ion-selective electrode (ISE)IVD General
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryClass B
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryIVD General
Calcium (Ca2+) IVD reagentCalcium (Ca2+) IVD reagentIVD General
Caldesmon protein IVD antibodyCaldesmon protein IVD antibodyIVD General
Calf implantCalf implantClass IIb
Calf/shin orthosisCalf/shin orthosis
Calf/shin orthosisCalf/shin orthosisClass I
Calibration gas cylinder regulatorCalibration gas cylinder regulatorClass 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
Calponin protein IVD kit enzyme immunohistochemistryCalponin protein IVD kit enzyme immunohistochemistryIVD General
Calprotectin IVD calibratorCalprotectin IVD calibratorIVD General
Calprotectin IVD controlCalprotectin IVD controlIVD General
Calprotectin IVD kit chemiluminescent immunoassayCalprotectin IVD kit chemiluminescent immunoassayIVD General
Calprotectin IVD kit enzyme immunoassay (EIA)Calprotectin IVD kit enzyme immunoassay (EIA)Class A
Calprotectin IVD kit enzyme immunoassay (EIA)Calprotectin IVD kit enzyme immunoassay (EIA)IVD Devices for Self-Testing
Calprotectin IVD kit enzyme immunoassay (EIA)Calprotectin IVD kit enzyme immunoassay (EIA)IVD General
Calprotectin IVD kit rapid ICT clinicalCalprotectin IVD kit rapid ICT clinicalIVD Devices for Self-Testing
Calprotectin IVD kit rapid ICT clinicalCalprotectin IVD kit rapid ICT clinicalIVD General
Calprotectin IVD reagentCalprotectin IVD reagentIVD 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 antibodyClass C
Calretinin protein IVD antibodyCalretinin protein IVD antibodyIVD General
Calretinin protein IVD kit enzyme immunohistochemistryCalretinin protein IVD kit enzyme immunohistochemistryIVD General
Camera application softwareCamera application software
Camera application softwareCamera application softwareClass I
Camera control unitCamera control unitClass 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
Campylobacter species broth culture medium IVDCampylobacter species broth culture medium IVDIVD General
Canalith repositioning procedure chair manualCanalith repositioning procedure chair manualClass IIa
Cancer-related multiple gene mutation profile IVD controlCancer-related multiple gene mutation profile IVD controlIVD General
Cancer-related multiple gene mutation profile kit IVDCancer-related multiple gene mutation profile kit IVDIVD General
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 immunoassayClass C
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)Class C
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 enzyme immunohistochemistryCancer antigen 125 (CA125) IVD kit enzyme immunohistochemistryIVD General
Cancer antigen 125 (CA125) IVD kit fluorescent immunoassayCancer antigen 125 (CA125) IVD kit fluorescent immunoassayIVD General
Cancer antigen 125 (CA125) IVD kit radioimmunoassayCancer antigen 125 (CA125) IVD kit radioimmunoassayIVD General
Cancer antigen 125 (CA125) IVD kit rapid ICT clinicalCancer antigen 125 (CA125) IVD kit rapid ICT clinicalIVD General
Cancer antigen 125 (CA125) IVD reagentCancer antigen 125 (CA125) IVD reagentIVD General
Cancer antigen 15-3 (CA15-3) IVD calibratorCancer antigen 15-3 (CA15-3) IVD calibratorClass C
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)Class C
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 fluorescent immunoassayCancer antigen 15-3 (CA15-3) IVD kit fluorescent immunoassayIVD General
Cancer antigen 15-3 (CA15-3) IVD kit radioimmunoassayCancer antigen 15-3 (CA15-3) IVD kit radioimmunoassayIVD General
Cancer antigen 15-3 (CA15-3) IVD kit rapid ICT clinicalCancer antigen 15-3 (CA15-3) IVD kit rapid ICT clinicalIVD 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 enzyme immunohistochemistryCancer antigen 19-9 (CA19-9) IVD kit enzyme immunohistochemistryIVD General
Cancer antigen 19-9 (CA19-9) IVD kit fluorescent immunoassayCancer antigen 19-9 (CA19-9) IVD kit fluorescent immunoassayIVD General
Cancer antigen 19-9 (CA19-9) IVD kit radioimmunoassayCancer antigen 19-9 (CA19-9) IVD kit radioimmunoassayIVD General
Cancer antigen 19-9 (CA19-9) IVD kit rapid ICT clinicalCancer antigen 19-9 (CA19-9) IVD kit rapid ICT clinicalIVD General
Cancer antigen 19-9 (CA19-9) IVD reagentCancer antigen 19-9 (CA19-9) IVD reagentIVD General
Cancer antigen 195 (CA195) IVD reagentCancer antigen 195 (CA195) IVD reagentIVD General
Cancer antigen 242 (CA242) IVD controlCancer antigen 242 (CA242) IVD controlIVD General
Cancer antigen 242 (CA242) IVD kit chemiluminescent immunoassayCancer antigen 242 (CA242) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 242 (CA242) IVD reagentCancer antigen 242 (CA242) IVD reagentIVD General
Cancer antigen 27-29 (CA27-29) IVD calibratorCancer antigen 27-29 (CA27-29) IVD calibratorIVD General
Cancer antigen 27-29 (CA27-29) IVD kit chemiluminescent immunoassayCancer antigen 27-29 (CA27-29) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 27-29 (CA27-29) IVD reagentCancer antigen 27-29 (CA27-29) IVD reagentIVD General
Cancer antigen 50 (CA50) IVD controlCancer antigen 50 (CA50) IVD controlIVD General
Cancer antigen 50 (CA50) IVD kit chemiluminescent immunoassayCancer antigen 50 (CA50) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 50 (CA50) IVD reagentCancer antigen 50 (CA50) IVD reagentIVD 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 calibratorClass C
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 antigen 72-4 (CA72-4) IVD kit enzyme immunoassay (EIA)Cancer antigen 72-4 (CA72-4) IVD kit enzyme immunoassay (EIA)IVD General
Cancer antigen 72-4 (CA72-4) IVD reagentCancer antigen 72-4 (CA72-4) IVD reagentClass C
Cancer antigen 72-4 (CA72-4) IVD reagentCancer antigen 72-4 (CA72-4) IVD reagentIVD General
Cancer associated serum antigen (CASA) IVD kit enzyme immunoassay (EIA)Cancer associated serum antigen (CASA) IVD kit enzyme immunoassay (EIA)IVD General
Cancer associated serum antigen (CASA) IVD reagentCancer associated serum antigen (CASA) IVD reagentIVD General
Cancer cell chemosensitivity assay kit IVDCancer cell chemosensitivity assay kit IVDIVD General
Cancer cell magnetic separation kit IVDCancer cell magnetic separation kit IVDIVD General
Cancer marker/gene/chemosensitivity profile kit IVDCancer marker/gene/chemosensitivity profile kit IVDIVD General
Cancer risk assessment interpretive software IVDCancer risk assessment interpretive software IVDIVD General
Cancer risk self-assessment interpretive softwareCancer risk self-assessment interpretive softwareClass I
Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayCancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayClass C
Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayCancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayIVD General
Cancer/tumour-associated aneuploidy IVD probeCancer/tumour-associated aneuploidy IVD probeIVD General