Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD reagentBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD reagentIVD General
Beta-haemolytic Group A Streptococcus total antibody IVD kit agglutinationBeta-haemolytic Group A Streptococcus total antibody IVD kit agglutinationIVD 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 agglutination rapidBeta-haemolytic multiple group Streptococcus streptolysin O antibody IVD kit agglutination rapidIVD 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 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
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
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
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 systemClass 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
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 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
Blanket/pad infant phototherapy unitBlanket/pad infant phototherapy unitClass IIa
Blaser-Wang Campylobacter species agar culture medium IVDBlaser-Wang Campylobacter species agar culture medium IVDIVD General
Blepharoplasty scissorsBlepharoplasty scissorsClass I
Block-monitoring peripheral nerve electrical stimulation systemBlock-monitoring peripheral nerve electrical stimulation systemClass I
Block-monitoring peripheral nerve electrical stimulation systemBlock-monitoring peripheral nerve electrical stimulation systemClass IIa
Block-monitoring peripheral nerve electrical stimulation systemBlock-monitoring peripheral nerve electrical stimulation systemClass IIb
Blood access tubing crimping pliersBlood access tubing crimping pliersClass I
Blood autotransfusion system tubingBlood autotransfusion system tubingClass IIa
Blood bag transport containerBlood bag transport containerClass IIa
Blood bank information system application softwareBlood bank information system application softwareClass I
Blood bank information system application softwareBlood bank information system application softwareClass IIb
Blood bank information systemBlood bank information systemClass I
Blood cell freeze/thaw system setBlood cell freeze/thaw system setClass IIa
Blood cell freeze/thaw system setBlood cell freeze/thaw system setClass IIb
Blood cell freeze/thaw systemBlood cell freeze/thaw systemClass IIa
Blood cell harvesting systemBlood cell harvesting systemClass IIa
Blood cell harvesting systemBlood cell harvesting systemClass IIb
Blood cell lysis reagent IVDBlood cell lysis reagent IVDClass A
Blood cell lysis reagent IVDBlood cell lysis reagent IVDIVD General
Blood cell preservation/storage/dilution solution IVDBlood cell preservation/storage/dilution solution IVDIVD General
Blood centrifugation system containment kitBlood centrifugation system containment kitClass I
Blood centrifugation system containment kitBlood centrifugation system containment kitClass IIa
Blood centrifugation system containment kitBlood centrifugation system containment kitClass IIb
Blood centrifugation system processing unitBlood centrifugation system processing unitClass IIa
Blood collection paperBlood collection paperClass I
Blood collection set invasiveBlood collection set invasiveClass IIa
Blood collection set noninvasiveBlood collection set noninvasiveClass A
Blood collection tube holder reusableBlood collection tube holder reusableClass I
Blood collection tube holder single-useBlood collection tube holder single-useClass I
Blood collection tube holder/needleBlood collection tube holder/needleClass IIa
Blood collection tube spike syringe adaptorBlood collection tube spike syringe adaptorClass I
Blood collection tube spike syringe adaptorBlood collection tube spike syringe adaptorClass IIa
Blood component separator automatedBlood component separator automatedClass I
Blood culture analyser IVD automatedBlood culture analyser IVD automatedClass A
Blood culture analyser IVD automatedBlood culture analyser IVD automatedIVD General
Blood culture broth kit IVDBlood culture broth kit IVDClass A
Blood culture broth kit IVDBlood culture broth kit IVDIVD General
Blood donation rockerBlood donation rockerClass I
Blood donation rockerBlood donation rockerClass IIa
Blood donor bag segment sampling IVDBlood donor bag segment sampling IVDIVD General
Blood donor bag tube divider/sealerBlood donor bag tube divider/sealerClass I
Blood donor chair/couchBlood donor chair/couch
Blood donor chair/couchBlood donor chair/couchClass I
Blood donor set double-packBlood donor set double-packClass IIb
Blood donor set many-packBlood donor set many-packClass IIb
Blood donor set quad-packBlood donor set quad-packClass IIb
Blood donor set quin-packBlood donor set quin-packClass IIb
Blood donor set single-packBlood donor set single-packClass IIb
Blood donor set triple-packBlood donor set triple-packClass IIb
Blood flowmeter catheter DopplerBlood flowmeter catheter DopplerClass IIb
Blood flowmeter transducer non-indwellingBlood flowmeter transducer non-indwellingClass IIa
Blood flowmeter transducer non-indwellingBlood flowmeter transducer non-indwellingClass III
Blood gas analyser IVD laboratory semi-automatedBlood gas analyser IVD laboratory semi-automatedIVD General
Blood gas analyser IVD point-of-careBlood gas analyser IVD point-of-careIVD General
Blood gas electrode carbon dioxideBlood gas electrode carbon dioxideIVD General
Blood gas pCO2 IVD kit ion-selective electrode (ISE)Blood gas pCO2 IVD kit ion-selective electrode (ISE)IVD General
Blood gas pH IVD kit ion-selective electrode (ISE)Blood gas pH IVD kit ion-selective electrode (ISE)IVD General