Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Brain spatulaBrain spatulaClass I
Brain spatulaBrain spatulaClass III
BRCA1 protein IVD kit enzyme immunohistochemistryBRCA1 protein IVD kit enzyme immunohistochemistryIVD General
BRCA1/BRCA2 genotyping IVD kit nucleic acid sequencing techniqueBRCA1/BRCA2 genotyping IVD kit nucleic acid sequencing techniqueIVD General
Breast-contact infant feeding tubeBreast-contact infant feeding tubeClass I
Breast binder reusableBreast binder reusableClass I
Breast carcinoma antigen 225 (BCA-225) IVD antibodyBreast carcinoma antigen 225 (BCA-225) IVD antibodyIVD General
Breast carcinoma antigen 225 (BCA-225) IVD kit enzyme immunohistochemistryBreast carcinoma antigen 225 (BCA-225) IVD kit enzyme immunohistochemistryIVD General
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 microwave imaging systemBreast microwave imaging system
Breast milk analyser IVDBreast milk analyser IVDIVD General
Breast pump electricBreast pump electricClass IIa
Breast pump manualBreast pump manualClass I
Breast pump manualBreast pump manualClass IIa
Breast pump support kit reusableBreast pump support kit reusableClass I
Breast pump support kit reusableBreast pump support kit reusableClass IIa
Breast pump support kit single-useBreast pump support kit single-useClass IIa
Breast ultrasound imaging systemBreast ultrasound imaging systemClass IIa
Breath ketone IVD kit rapid colorimetric clinicalBreath ketone IVD kit rapid colorimetric clinicalIVD 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 catheter mount single-useBreathing circuit catheter mount single-useClass IIb
Breathing circuit condensate trap reusableBreathing circuit condensate trap reusableClass I
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 dryer closedBreathing circuit dryer closedClass I
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 I
Breathing circuit multi-parameter sensorBreathing circuit multi-parameter sensorClass IIa
Breathing circuit multi-parameter sensorBreathing circuit multi-parameter sensorClass IIb
Breathing circuit tube holderBreathing circuit tube holderClass I
Breathing circuit tube holderBreathing circuit tube holderClass IIb
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 IVDClass A
Bromelin immunohaematology reagent IVDBromelin immunohaematology reagent IVDIVD General
Bromocresol purple (BCP) agar culture medium IVDBromocresol purple (BCP) agar culture medium IVDIVD General
Bronchial balloon catheterBronchial balloon catheterClass I
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 reusableBronchoscopic biopsy curette flexible reusableClass I
Bronchoscopic biopsy curette flexible single-useBronchoscopic biopsy curette flexible single-useClass IIa
Bronchoscopic catheterBronchoscopic catheterClass IIa
Bronchoscopic specimen collection containerBronchoscopic specimen collection containerClass I
Bronchoscopy tubeBronchoscopy tubeClass I
Bronchoscopy tubeBronchoscopy tubeClass IIa
Broth Media (Bottles)Broth Media (Bottles)IVD General
Broth Media (Tubes)Broth Media (Tubes)IVD General
Broth only (Blood Culture - Manual)Broth only (Blood Culture - Manual)IVD General
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 reagentClass A
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
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)Class B
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)Class B
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 gel Conformity Assessment Certificate ExpiredClass IIb
Burn gelBurn gelClass I
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 IIa
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 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 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 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 agglutination clinicalC-reactive protein (CRP) IVD kit rapid agglutination clinicalIVD 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 calibratorC-X-C motif chemokine ligand 13 (CXCL13) IVD calibratorIVD 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 calibratorClass B
Calprotectin IVD calibratorCalprotectin IVD calibratorIVD General
Calprotectin IVD controlCalprotectin IVD controlClass B
Calprotectin IVD controlCalprotectin IVD controlIVD General