Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
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 calibratorClass C
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 radioimmunoassayClass C
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 immunoassayClass C
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 radioimmunoassayClass C
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 radioimmunoassayClass C
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 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 calibratorClass C
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 immunoassayClass C
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 reagentClass C
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 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 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 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
Candida albicans antigen IVD controlCandida albicans antigen IVD controlIVD 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 G (IgG) antibody IVD kit fluorescent immunoassayCandida albicans immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayIVD General
Candida albicans immunoglobulin G (IgG) antibody IVD reagentCandida albicans immunoglobulin G (IgG) antibody IVD reagentIVD General
Candida albicans immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)Candida albicans immunoglobulin G (IgG)/IgM 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 auris nucleic acid IVD kit nucleic acid technique (NAT)Candida auris nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Candida species agar culture medium IVD basicCandida species agar culture medium IVD basicIVD General
Candida species mannan antigen IVD kit enzyme immunoassay (EIA)Candida species mannan antigen IVD kit enzyme immunoassay (EIA)IVD General
Cannabinoid/cannabinoid metabolite IVD calibratorCannabinoid/cannabinoid metabolite IVD calibratorIVD General
Cannabinoid/cannabinoid metabolite IVD controlCannabinoid/cannabinoid metabolite IVD controlIVD General
Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)IVD General
Cannabinoid/cannabinoid metabolite IVD kit rapid ICT clinicalCannabinoid/cannabinoid metabolite IVD kit rapid ICT clinicalIVD General
Cannabinoid/cannabinoid metabolite IVD reagentCannabinoid/cannabinoid metabolite IVD reagentIVD General
Cannula clampCannula clampClass I
Cannulae (Reusable)Cannulae (Reusable)Class I
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass I
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIb
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass III
Cannulated surgical drill bit single-use non-sterileCannulated surgical drill bit single-use non-sterileClass I
Cannulated surgical drill bit single-use non-sterileCannulated surgical drill bit single-use non-sterileClass IIa
Cannulated surgical drill bit single-useCannulated surgical drill bit single-use Conformity Assessment Certificate ExpiredClass IIa
Cannulated surgical drill bit single-useCannulated surgical drill bit single-useClass IIa
Cannulated surgical drill bit single-useCannulated surgical drill bit single-useClass IIb
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass IIa
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass IIb
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass III
Capillary blood collection funnelCapillary blood collection funnelClass I
Capillary blood collection kit home-useCapillary blood collection kit home-use
Capillary blood collection kit home-useCapillary blood collection kit home-useClass I
Capillary blood collection kit home-useCapillary blood collection kit home-useClass IIa
Capillary blood collection kit home-useCapillary blood collection kit home-useIVD General
Capillary blood collection system IVDCapillary blood collection system IVDIVD General
Capillary blood collection tube IVD ammonium heparinCapillary blood collection tube IVD ammonium heparinIVD General
Capillary blood collection tube IVD electrolyte-balanced heparinCapillary blood collection tube IVD electrolyte-balanced heparinClass A
Capillary blood collection tube IVD electrolyte-balanced heparinCapillary blood collection tube IVD electrolyte-balanced heparinIVD General
Capillary blood collection tube IVD K2EDTACapillary blood collection tube IVD K2EDTAClass A
Capillary blood collection tube IVD K2EDTACapillary blood collection tube IVD K2EDTAIVD General
Capillary blood collection tube IVD lithium heparinCapillary blood collection tube IVD lithium heparinClass A
Capillary blood collection tube IVD lithium heparinCapillary blood collection tube IVD lithium heparinIVD General
Capillary blood collection tube IVD no additiveCapillary blood collection tube IVD no additiveClass A
Capillary blood collection tube IVD no additiveCapillary blood collection tube IVD no additiveIVD General
Capillary blood collection tube IVD sodium heparinCapillary blood collection tube IVD sodium heparinClass A
Capillary blood collection tube IVD sodium heparinCapillary blood collection tube IVD sodium heparinIVD General
Capillary blood pump IVDCapillary blood pump IVDIVD General
Capillary blood transfer tube IVD EDTACapillary blood transfer tube IVD EDTAClass A
Capillary blood transfer tube IVD heparinCapillary blood transfer tube IVD heparinClass A
Capillary blood transfer tube IVD heparinCapillary blood transfer tube IVD heparinIVD General
Capillary patient thermometer gallium-alloyCapillary patient thermometer gallium-alloyClass I
Capnography oxygen maskCapnography oxygen mask Conformity Assessment Certificate ExpiredClass IIa
Capnography oxygen maskCapnography oxygen maskClass IIa
Capnography sampling adaptorCapnography sampling adaptorClass IIa
Capsular tension ring inserterCapsular tension ring inserterClass I
Capsular tension ringCapsular tension ring Conformity Assessment Certificate ExpiredClass IIb
Capsular tension ringCapsular tension ringClass IIb
Carbamazepine therapeutic drug monitoring IVD calibratorCarbamazepine therapeutic drug monitoring IVD calibratorIVD General
Carbamazepine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Carbamazepine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Carbamazepine therapeutic drug monitoring IVD kit nephelometry/turbidimetryCarbamazepine therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Carbamazepine therapeutic drug monitoring IVD reagentCarbamazepine therapeutic drug monitoring IVD reagentIVD General
Carbamazepinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayCarbamazepinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Carbenicillin susceptibility testing disc IVDCarbenicillin susceptibility testing disc IVDIVD General
Carbide dental bur reusableCarbide dental bur reusable Conformity Assessment Certificate ExpiredClass IIa
Carbide dental bur reusableCarbide dental bur reusable
Carbide dental bur reusableCarbide dental bur reusableClass I
Carbide dental bur reusableCarbide dental bur reusableClass IIa
Carbide dental bur single-useCarbide dental bur single-useClass IIa
Carbohydrate deficient transferrin IVD calibratorCarbohydrate deficient transferrin IVD calibratorIVD General
Carbohydrate deficient transferrin IVD controlCarbohydrate deficient transferrin IVD controlIVD General
Carbohydrate deficient transferrin IVD kit electrophoresisCarbohydrate deficient transferrin IVD kit electrophoresisIVD General
Carbohydrate deficient transferrin IVD kit liquid chromatographyCarbohydrate deficient transferrin IVD kit liquid chromatographyIVD General
Carbohydrate deficient transferrin IVD reagentCarbohydrate deficient transferrin IVD reagentIVD General
Carbon dioxide absorbent cartridgeCarbon dioxide absorbent cartridgeClass IIa
Carbon dioxide absorbent solution IVDCarbon dioxide absorbent solution IVDClass A
Carbon dioxide absorbentCarbon dioxide absorbentClass I
Carbon dioxide absorbentCarbon dioxide absorbentClass IIa
Carbon dioxide absorber reusableCarbon dioxide absorber reusableClass IIa
Carbon dioxide absorber reusableCarbon dioxide absorber reusableClass IIb
Carbon dioxide absorber single-useCarbon dioxide absorber single-useClass I
Carbon dioxide absorber single-useCarbon dioxide absorber single-useClass IIa
Carbon dioxide breath analyser home-useCarbon dioxide breath analyser home-useClass I
Carbon dioxide breath analyser sampling chamberCarbon dioxide breath analyser sampling chamberClass I
Carbon dioxide cartridge non-sterileCarbon dioxide cartridge non-sterileClass IIa
Carbon dioxide cuvette reusableCarbon dioxide cuvette reusableClass IIa
Carbon dioxide cuvette single-useCarbon dioxide cuvette single-useClass IIa
Carbon dioxide gas cartridgeCarbon dioxide gas cartridgeClass I
Carbon dioxide gas cartridgeCarbon dioxide gas cartridgeClass IIa
Carbon dioxide laboratory incubatorCarbon dioxide laboratory incubatorClass I
Carbon dioxide laboratory incubatorCarbon dioxide laboratory incubatorClass IIa
Carbon dioxide monitorCarbon dioxide monitorClass IIb
Carbon dioxide sensor/cableCarbon dioxide sensor/cableClass IIb
Carbon dioxide (CO2) IVD calibratorCarbon dioxide (CO2) IVD calibratorIVD General
Carbon dioxide (CO2) IVD controlCarbon dioxide (CO2) IVD controlIVD General
Carbon dioxide (CO2) IVD kit spectrophotometryCarbon dioxide (CO2) IVD kit spectrophotometryIVD General
Carbon dioxide (CO2) IVD reagentCarbon dioxide (CO2) IVD reagentIVD General
Carbon monoxide breath analyserCarbon monoxide breath analyser Conformity Assessment Certificate ExpiredClass IIa
Carbon monoxide breath analyserCarbon monoxide breath analyserClass I
Carbon monoxide breath analyserCarbon monoxide breath analyserClass IIa
Carbonic anhydrase IVD antibodyCarbonic anhydrase IVD antibodyIVD General
Carbonic bone filling/substitute implantCarbonic bone filling/substitute implantClass III
Carboxymethylcellulose sodium denture adhesiveCarboxymethylcellulose sodium denture adhesiveClass I
Carboxymethylcellulose sodium/cationic polyacrylamide polymer denture adhesiveCarboxymethylcellulose sodium/cationic polyacrylamide polymer denture adhesiveClass I
Carboxymethylcellulose sodium/polymer denture adhesive zinc-containingCarboxymethylcellulose sodium/polymer denture adhesive zinc-containingClass I
Carboxymethylcellulose sodium/polymer denture adhesive zinc-containingCarboxymethylcellulose sodium/polymer denture adhesive zinc-containingClass IIa
Carboxymethylcellulose sodium/polymer denture adhesive zinc-freeCarboxymethylcellulose sodium/polymer denture adhesive zinc-freeClass I
Carcinoembryonic antigen (CEA) IVD antibodyCarcinoembryonic antigen (CEA) IVD antibodyIVD General
Carcinoembryonic antigen (CEA) IVD calibratorCarcinoembryonic antigen (CEA) IVD calibratorIVD General
Carcinoembryonic antigen (CEA) IVD controlCarcinoembryonic antigen (CEA) IVD controlIVD General
Carcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayCarcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayClass C
Carcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayCarcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit enzyme immunoassay (EIA)Carcinoembryonic antigen (CEA) IVD kit enzyme immunoassay (EIA)IVD General
Carcinoembryonic antigen (CEA) IVD kit enzyme immunohistochemistryCarcinoembryonic antigen (CEA) IVD kit enzyme immunohistochemistryIVD General
Carcinoembryonic antigen (CEA) IVD kit fluorescent immunoassayCarcinoembryonic antigen (CEA) IVD kit fluorescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit radioimmunoassayCarcinoembryonic antigen (CEA) IVD kit radioimmunoassayClass C
Carcinoembryonic antigen (CEA) IVD kit radioimmunoassayCarcinoembryonic antigen (CEA) IVD kit radioimmunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinicalCarcinoembryonic antigen (CEA) IVD kit rapid ICT clinicalIVD General
Carcinoembryonic antigen (CEA) IVD reagentCarcinoembryonic antigen (CEA) IVD reagentIVD General
Cardiac-therapy vagus nerve electrical stimulation systemCardiac-therapy vagus nerve electrical stimulation system
Cardiac ablation laser system beam guide-catheterCardiac ablation laser system beam guide-catheter Conformity Assessment Certificate ExpiredClass III
Cardiac ablation solid-state laser systemCardiac ablation solid-state laser system Conformity Assessment Certificate ExpiredClass IIb
Cardiac ablation system applicator introducer/sizerCardiac ablation system applicator introducer/sizerClass IIa
Cardiac ablation system irrigation tubing setCardiac ablation system irrigation tubing set Conformity Assessment Certificate ExpiredClass IIa
Cardiac ablation system irrigation tubing setCardiac ablation system irrigation tubing setClass I
Cardiac ablation system irrigation tubing setCardiac ablation system irrigation tubing setClass IIa
Cardiac ablation system irrigation tubing setCardiac ablation system irrigation tubing setClass IIb