Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Bench-top keratometerBench-top keratometerClass IIa
Benchtop nebulizer heatedBenchtop nebulizer heatedClass IIa
Benchtop nebulizer non-heatedBenchtop nebulizer non-heated Conformity Assessment Certificate ExpiredClass IIa
Benchtop nebulizer non-heatedBenchtop nebulizer non-heated
Benchtop nebulizer non-heatedBenchtop nebulizer non-heatedClass I
Benchtop nebulizer non-heatedBenchtop nebulizer non-heatedClass IIa
Benchtop nebulizer non-heatedBenchtop nebulizer non-heatedClass IIb
Benzodiazepine group IVD calibratorBenzodiazepine group IVD calibratorIVD General
Benzodiazepine group IVD controlBenzodiazepine group IVD controlIVD General
Benzodiazepine group IVD kit enzyme immunoassay (EIA)Benzodiazepine group IVD kit enzyme immunoassay (EIA)IVD General
Benzodiazepine group IVD kit rapid ICT clinicalBenzodiazepine group IVD kit rapid ICT clinicalIVD General
Benzodiazepine group therapeutic drug monitoring IVD kit liquid chromatography/mass spectrometry (LC/MS)Benzodiazepine group therapeutic drug monitoring IVD kit liquid chromatography/mass spectrometry (LC/MS)IVD General
Benzodiazepine group therapeutic drug monitoring IVD reagentBenzodiazepine group therapeutic drug monitoring IVD reagentIVD General
Beta-2-glycoprotein I antibody IVD controlBeta-2-glycoprotein I antibody IVD controlIVD General
Beta-2-glycoprotein I antibody IVD kit chemiluminescent immunoassayBeta-2-glycoprotein I antibody IVD kit chemiluminescent immunoassayIVD General
Beta-2-glycoprotein I antibody IVD kit enzyme immunoassay (EIA)Beta-2-glycoprotein I antibody IVD kit enzyme immunoassay (EIA)IVD General
Beta-2-glycoprotein I antibody IVD kit fluorescent immunoassayBeta-2-glycoprotein I antibody IVD kit fluorescent immunoassayIVD General
Beta-2-microglobulin IVD antibodyBeta-2-microglobulin IVD antibodyIVD General
Beta-2-microglobulin IVD calibratorBeta-2-microglobulin IVD calibratorIVD General
Beta-2-microglobulin IVD controlBeta-2-microglobulin IVD controlIVD General
Beta-2-microglobulin IVD kit chemiluminescent immunoassayBeta-2-microglobulin IVD kit chemiluminescent immunoassayIVD General
Beta-2-microglobulin IVD kit enzyme immunoassay (EIA)Beta-2-microglobulin IVD kit enzyme immunoassay (EIA)IVD General
Beta-2-microglobulin IVD kit nephelometry/turbidimetryBeta-2-microglobulin IVD kit nephelometry/turbidimetryIVD General
Beta-2-microglobulin IVD kit radioimmunoassayBeta-2-microglobulin IVD kit radioimmunoassayIVD General
Beta-2-microglobulin IVD kit rapid ICT clinicalBeta-2-microglobulin IVD kit rapid ICT clinicalIVD General
Beta-2-microglobulin IVD reagentBeta-2-microglobulin IVD reagentIVD General
Beta-2-transferrin IVD kit electrophoresisBeta-2-transferrin IVD kit electrophoresisIVD General
Beta-catenin IVD antibodyBeta-catenin IVD antibodyIVD General
Beta-catenin IVD kit enzyme immunohistochemistryBeta-catenin IVD kit enzyme immunohistochemistryIVD General
Beta-dystroglycan IVD antibodyBeta-dystroglycan IVD antibodyIVD General
Beta-haemolytic Group A Streptococcus antigen IVD controlBeta-haemolytic Group A Streptococcus antigen IVD controlIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit agglutinationBeta-haemolytic Group A Streptococcus antigen IVD kit agglutinationIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit fluorescent immunoassayBeta-haemolytic Group A Streptococcus antigen IVD kit fluorescent immunoassayIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD Devices for Self-Testing
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT self-testingBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT self-testingIVD Devices for Self-Testing
Beta-haemolytic Group A Streptococcus DNAse B antibody IVD kit enzyme immunoassay (EIA)Beta-haemolytic Group A Streptococcus DNAse B antibody IVD kit enzyme immunoassay (EIA)IVD General
Beta-haemolytic Group A Streptococcus DNAse B antibody IVD kit nephelometry/turbidimetryBeta-haemolytic Group A Streptococcus DNAse B antibody IVD kit nephelometry/turbidimetryIVD General
Beta-haemolytic Group A Streptococcus DNAse B antibody IVD reagentBeta-haemolytic Group A Streptococcus DNAse B antibody IVD reagentIVD General
Beta-haemolytic Group A Streptococcus hyaluronidase antibody IVD kit enzyme immunoassay (EIA)Beta-haemolytic Group A Streptococcus hyaluronidase antibody IVD kit enzyme immunoassay (EIA)IVD General
Beta-haemolytic Group A Streptococcus multiple enzyme antibody IVD reagentBeta-haemolytic Group A Streptococcus multiple enzyme antibody IVD reagentIVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD controlBeta-haemolytic Group A Streptococcus nucleic acid IVD controlClass B
Beta-haemolytic Group A Streptococcus nucleic acid IVD controlBeta-haemolytic Group A Streptococcus nucleic acid IVD controlIVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Class B
Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibratorBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibratorIVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD controlBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD controlIVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit enzyme immunoassay (EIA)Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit enzyme immunoassay (EIA)IVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit fluorescent immunoassayBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit fluorescent immunoassayIVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit nephelometry/turbidimetryBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit nephelometry/turbidimetryIVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD reagentBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD reagentIVD General
Beta-haemolytic Group B Streptococcus antigen IVD controlBeta-haemolytic Group B Streptococcus antigen IVD controlIVD General
Beta-haemolytic Group B Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group B Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD controlBeta-haemolytic Group B Streptococcus nucleic acid IVD controlIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD reagentBeta-haemolytic Group B Streptococcus nucleic acid IVD reagentIVD General
Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD kit rapid agglutination clinicalBeta-haemolytic multiple group Streptococcus streptolysin O antibody IVD kit rapid agglutination clinicalIVD General
Beta-haemolytic Streptococcus serological grouping IVD controlBeta-haemolytic Streptococcus serological grouping IVD controlIVD General
Beta-haemolytic Streptococcus serological grouping IVD kit agglutinationBeta-haemolytic Streptococcus serological grouping IVD kit agglutinationIVD General
Beta-haemolytic Streptococcus serological grouping IVD reagentBeta-haemolytic Streptococcus serological grouping IVD reagentIVD General
Beta-hydroxybutyrate dehydrogenase IVD kit enzyme spectrophotometryBeta-hydroxybutyrate dehydrogenase IVD kit enzyme spectrophotometryIVD General
Beta-hydroxybutyrate dehydrogenase IVD reagentBeta-hydroxybutyrate dehydrogenase IVD reagentIVD General
Beta-hydroxybutyrate IVD calibratorBeta-hydroxybutyrate IVD calibratorIVD General
Beta-hydroxybutyrate IVD controlBeta-hydroxybutyrate IVD controlIVD Devices for Self-Testing
Beta-hydroxybutyrate IVD controlBeta-hydroxybutyrate IVD controlIVD General
Beta-hydroxybutyrate IVD kit enzyme spectrophotometryBeta-hydroxybutyrate IVD kit enzyme spectrophotometryIVD General
Beta-hydroxybutyrate IVD reagentBeta-hydroxybutyrate IVD reagentIVD Devices for Self-Testing
Beta-hydroxybutyrate IVD reagentBeta-hydroxybutyrate IVD reagentIVD General
Beta-lactamase activity IVD kit mass spectrometryBeta-lactamase activity IVD kit mass spectrometryIVD General
Beta-lactamase detection reagent IVDBeta-lactamase detection reagent IVDClass A
Beta-lactamase detection reagent IVDBeta-lactamase detection reagent IVDIVD General
Beta-lactamase production microbial reagent IVDBeta-lactamase production microbial reagent IVDClass A
Beta-lactamase production microbial reagent IVDBeta-lactamase production microbial reagent IVDIVD General
Beta-thromboglobulin IVD kit enzyme immunoassay (EIA)Beta-thromboglobulin IVD kit enzyme immunoassay (EIA)IVD General
Beverage thickness assessment toolBeverage thickness assessment toolClass I
Bib/apron adult reusableBib/apron adult reusableClass I
Bib/apron adult single-useBib/apron adult single-useClass I
Bicaval valve bioprosthesisBicaval valve bioprosthesisClass III
Bicompartmental knee prosthesisBicompartmental knee prosthesis
Bicompartmental knee prosthesisBicompartmental knee prosthesisClass III
Bicycle ergometerBicycle ergometerClass I
Bicycle ergometerBicycle ergometerClass IIa
Bicycle exerciserBicycle exerciserClass I
Bicycle exerciserBicycle exerciserClass IIa
Bidet portableBidet portableClass I
Bidirectional-anaesthesia breathing circuitBidirectional-anaesthesia breathing circuitClass I
Bile esculin differentiation disc IVDBile esculin differentiation disc IVDIVD General
Bile esculin Enterococcus species agar culture medium IVDBile esculin Enterococcus species agar culture medium IVDIVD General
Bile solubility microbial reagent IVDBile solubility microbial reagent IVDClass A
Bile solubility microbial reagent IVDBile solubility microbial reagent IVDIVD General
Biliary drainBiliary drain Conformity Assessment Certificate ExpiredClass IIb
Biliary drainBiliary drain
Biliary drainBiliary drainClass I
Biliary drainBiliary drainClass IIa
Biliary drainBiliary drainClass IIb
Biliary/urinary stone retrieval basket reusableBiliary/urinary stone retrieval basket reusableClass I
Biliary/urinary stone retrieval basket reusableBiliary/urinary stone retrieval basket reusableClass IIa
Biliary/urinary stone retrieval basket single-useBiliary/urinary stone retrieval basket single-useClass I
Biliary/urinary stone retrieval basket single-useBiliary/urinary stone retrieval basket single-useClass IIa
Biliary/vascular irrigation catheterBiliary/vascular irrigation catheterClass IIa
Bilirubin monitoring system IVDBilirubin monitoring system IVDIVD General
Bilirubinometer IVDBilirubinometer IVDIVD General
Binaural beats softwareBinaural beats software
Binocular vision test unitBinocular vision test unitClass I
Bioabsorbable long bone nailBioabsorbable long bone nailClass III
Biochemically-interactive dressingBiochemically-interactive dressing Conformity Assessment Certificate ExpiredClass IIb
Biochemically-interactive dressingBiochemically-interactive dressing Conformity Assessment Certificate ExpiredClass III
Bioelectrical body composition analyserBioelectrical body composition analyserClass I
Bioelectrical body composition analyserBioelectrical body composition analyserClass IIa
Bioelectrical signal analysis softwareBioelectrical signal analysis software Conformity Assessment Certificate ExpiredClass I
Bioelectrical signal analysis softwareBioelectrical signal analysis softwareClass I
Bioelectrical signal analysis softwareBioelectrical signal analysis softwareClass IIa
Bioelectrical signal analysis softwareBioelectrical signal analysis softwareClass IIb
Bioengineered vascular graft animal-derivedBioengineered vascular graft animal-derivedClass III
Biofeedback system application softwareBiofeedback system application softwareClass I
Biofeedback systemBiofeedback system Conformity Assessment Certificate ExpiredClass IIa
Biological fluid specimen capillary collector IVDBiological fluid specimen capillary collector IVDIVD General
Biological fluid specimen collection cartridge IVDBiological fluid specimen collection cartridge IVDIVD General
Biological stain control IVDBiological stain control IVDClass A
Biological stain control IVDBiological stain control IVDIVD General
Biological stain IVDBiological stain IVDClass A
Biological stain IVDBiological stain IVDClass C
Biological stain IVDBiological stain IVDIVD General
Biological stain kit IVDBiological stain kit IVDIVD General
Biological sterilization indicatorBiological sterilization indicatorClass I
Biomechanical function analysis system force-testing portableBiomechanical function analysis system force-testing portableClass I
Biomechanical function analysis system force-testing stationaryBiomechanical function analysis system force-testing stationaryClass I
Biomechanical function analysis system force-testing stationaryBiomechanical function analysis system force-testing stationaryClass IIa
Biomechanical function analysis system motion-trackingBiomechanical function analysis system motion-tracking
Biomechanical function analysis system motion-trackingBiomechanical function analysis system motion-trackingClass I
Biomechanical function analysis/interactive rehabilitation systemBiomechanical function analysis/interactive rehabilitation system Conformity Assessment Certificate ExpiredClass I
Biomechanical function analysis/rehabilitation softwareBiomechanical function analysis/rehabilitation software Conformity Assessment Certificate ExpiredClass I
Biomechanical function analysis/rehabilitation softwareBiomechanical function analysis/rehabilitation software
Biomechanical function analysis/rehabilitation softwareBiomechanical function analysis/rehabilitation softwareClass I
Biomechanical function analysis/rehabilitation softwareBiomechanical function analysis/rehabilitation softwareClass IIa
Biopsy drill bitBiopsy drill bitClass I
Biopsy drill bitBiopsy drill bitClass IIa
Biopsy gun handpieceBiopsy gun handpieceClass I
Biopsy gun handpieceBiopsy gun handpieceClass IIa
Biopsy punch reusableBiopsy punch reusableClass I
Biopsy syringe holder single-useBiopsy syringe holder single-useClass I
Biopsy syringe holder single-useBiopsy syringe holder single-useClass IIa
Biopsy tissue marking dye kit IVDBiopsy tissue marking dye kit IVDClass A
Biopsy tissue marking dye kit IVDBiopsy tissue marking dye kit IVDIVD General
Biotin (vitamin H) IVD kit enzyme immunoassay (EIA)Biotin (vitamin H) IVD kit enzyme immunoassay (EIA)IVD General
Biphasic culture medium IVDBiphasic culture medium IVDIVD General
Bipolar femoral head outer component hemiarthroplastyBipolar femoral head outer component hemiarthroplasty
Bipolar femoral head outer component hemiarthroplastyBipolar femoral head outer component hemiarthroplastyClass IIb
Bipolar femoral head outer component hemiarthroplastyBipolar femoral head outer component hemiarthroplastyClass III
Bipolar humeral head outer componentBipolar humeral head outer component
Bipolar humeral head outer componentBipolar humeral head outer componentClass IIb
Bipolar partial shoulder prosthesisBipolar partial shoulder prosthesis
Bipolar partial shoulder prosthesisBipolar partial shoulder prosthesisClass IIb
Bipolar partial shoulder prosthesisBipolar partial shoulder prosthesisClass III
Birthing bed/table poweredBirthing bed/table poweredClass I
Birthing cushionBirthing cushionClass I
Birthing/delivery kitBirthing/delivery kit Conformity Assessment Certificate ExpiredClass IIa
Birthing/delivery kitBirthing/delivery kit
Birthing/delivery kitBirthing/delivery kitClass I
Birthing/delivery kitBirthing/delivery kitClass IIa
Bismuth sulphite Salmonella species agar culture medium IVDBismuth sulphite Salmonella species agar culture medium IVDIVD General
Bite registration rim wax plateBite registration rim wax plate
Bite registration rim wax plateBite registration rim wax plateClass I
Bite registration rim wax plateBite registration rim wax plateClass IIa
Bite registration rim waxBite registration rim wax
Bite registration rim waxBite registration rim waxClass I
Bite registration rim waxBite registration rim waxClass IIa
Bite registration rimBite registration rim
Bite registration rimBite registration rimClass I
Bite registration rimBite registration rimClass IIa
Bite relief padBite relief pad
Bite relief padBite relief padClass I
BK virus (BKV) antigen IVD controlBK virus (BKV) antigen IVD controlIVD General
BK virus (BKV) nucleic acid IVD calibratorBK virus (BKV) nucleic acid IVD calibratorIVD General
BK virus (BKV) nucleic acid IVD controlBK virus (BKV) nucleic acid IVD controlIVD General
BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)Class C
BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
BK virus (BKV) nucleic acid IVD reagentBK virus (BKV) nucleic acid IVD reagentIVD General
Bladder evacuator reusableBladder evacuator reusableClass I
Bladder evacuator reusableBladder evacuator reusableClass IIa
Bladder evacuator single-useBladder evacuator single-useClass I
Bladder evacuator single-useBladder evacuator single-useClass IIa
Bladder instillation barrierBladder instillation barrier
Bladder instillation barrierBladder instillation barrierClass IIa
Bladder instillation barrierBladder instillation barrierClass IIb
Bladder instillation barrierBladder instillation barrierClass III
Bladder irrigation kitBladder irrigation kit
Bladder irrigation kitBladder irrigation kitClass I
Bladder irrigation kitBladder irrigation kitClass IIa
Bladder neck spreaderBladder neck spreaderClass I
Bladder spatulaBladder spatulaClass I
Bladder tumour-associated mutation IVD controlBladder tumour-associated mutation IVD controlIVD General
Bladder tumour-associated mutation IVD kit nucleic acid technique (NAT)Bladder tumour-associated mutation IVD kit nucleic acid technique (NAT)IVD General
Bladder tumour-associated mutation IVD probeBladder tumour-associated mutation IVD probeIVD General
Bladder tumour associated antigen IVD kit rapid ICT clinicalBladder tumour associated antigen IVD kit rapid ICT clinicalIVD General
Bladder volume ultrasound imaging systemBladder volume ultrasound imaging systemClass IIa
Bladder/bowel-evacuation implantable electrical stimulation systemBladder/bowel-evacuation implantable electrical stimulation system
Blade jarBlade jarClass I
Blank antimicrobial susceptibility testing disc IVDBlank antimicrobial susceptibility testing disc IVDIVD General
Blanket warming cabinet steam-heatBlanket warming cabinet steam-heatClass I