Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Rigid rhinoscopeRigid rhinoscopeClass IIa
Rigid sigmoidoscopeRigid sigmoidoscopeClass I
Rigid sinoscopeRigid sinoscopeClass I
Rigid sinoscopeRigid sinoscopeClass IIa
Rigid ureterorenoscopeRigid ureterorenoscopeClass I
Rigid ureterorenoscopeRigid ureterorenoscopeClass IIa
Rigid ureteroscopeRigid ureteroscopeClass IIa
Rigid video hysteroscopeRigid video hysteroscopeClass IIa
Rigid video laparoscopeRigid video laparoscopeClass IIa
Rigid video thoracoscopeRigid video thoracoscopeClass IIa
Rigid video ureterorenoscopeRigid video ureterorenoscopeClass IIa
Ring cutterRing cutterClass I
Risperidone therapeutic drug monitoring IVD reagentRisperidone therapeutic drug monitoring IVD reagentIVD General
Rituximab antibody IVD kit enzyme immunoassay (EIA)Rituximab antibody IVD kit enzyme immunoassay (EIA)IVD General
Rituximab therapeutic drug monitoring IVD kit enzyme immunosassay (EIA)Rituximab therapeutic drug monitoring IVD kit enzyme immunosassay (EIA)IVD General
RNA polymerase III antibody (anti-Pol III) IVD kit enzyme immunoassay (EIA)RNA polymerase III antibody (anti-Pol III) IVD kit enzyme immunoassay (EIA)IVD General
Ro52 antibody (anti-Ro52)/Trim21 antibody IVD calibratorRo52 antibody (anti-Ro52)/Trim21 antibody IVD calibratorIVD General
Ro52 antibody (anti-Ro52)/Trim21 antibody IVD controlRo52 antibody (anti-Ro52)/Trim21 antibody IVD controlIVD General
Ro52antibody(anti-Ro52)/TRIM21antibodyIVD kit chemiluminescent immunoassayRo52antibody(anti-Ro52)/TRIM21antibodyIVD kit chemiluminescent immunoassayIVD General
Robotic electrosurgical instrument bipolar reusableRobotic electrosurgical instrument bipolar reusableClass IIa
Robotic electrosurgical instrument bipolar reusableRobotic electrosurgical instrument bipolar reusableClass IIb
Robotic electrosurgical instrument bipolar single-useRobotic electrosurgical instrument bipolar single-useClass IIb
Robotic electrosurgical instrument monopolar reusableRobotic electrosurgical instrument monopolar reusableClass IIa
Robotic electrosurgical instrument monopolar reusableRobotic electrosurgical instrument monopolar reusableClass IIb
Robotic surgical cutting stapler reusableRobotic surgical cutting stapler reusableClass IIa
Robotic surgical cutting stapler single-useRobotic surgical cutting stapler single-useClass IIa
Robotic surgical forceps reusableRobotic surgical forceps reusableClass IIa
Robotic surgical irrigation/aspiration cannula reusableRobotic surgical irrigation/aspiration cannula reusableClass IIa
Robotic surgical irrigation/aspiration cannula single-useRobotic surgical irrigation/aspiration cannula single-useClass IIa
Robotic surgical ligation clip applierRobotic surgical ligation clip applierClass IIa
Robotic surgical navigation system application softwareRobotic surgical navigation system application softwareClass I
Robotic surgical navigation system application softwareRobotic surgical navigation system application softwareClass IIa
Robotic surgical navigation systemRobotic surgical navigation system Conformity Assessment Certificate ExpiredClass IIa
Robotic surgical navigation systemRobotic surgical navigation system
Robotic surgical navigation systemRobotic surgical navigation systemClass I
Robotic surgical navigation systemRobotic surgical navigation systemClass IIa
Robotic surgical navigation systemRobotic surgical navigation systemClass IIb
Robotic surgical needle holder reusableRobotic surgical needle holder reusableClass IIa
Robotic surgical retractorRobotic surgical retractorClass IIa
Robotic surgical scissorsRobotic surgical scissorsClass IIa
Robotic surgical systemRobotic surgical system
Robotic surgical systemRobotic surgical systemClass I
Robotic surgical systemRobotic surgical systemClass IIa
Robotic surgical systemRobotic surgical systemClass IIb
Rocking infant bed manualRocking infant bed manualClass I
Rollator/MobilatorRollator/MobilatorClass I
Room humidifierRoom humidifierClass I
Root canal cleaning solutionRoot canal cleaning solutionClass I
Root canal cleaning solutionRoot canal cleaning solutionClass IIa
Root canal filling-removal solutionRoot canal filling-removal solutionClass IIa
Root canal irrigation blunt needleRoot canal irrigation blunt needleClass I
Root canal irrigation blunt needleRoot canal irrigation blunt needleClass IIa
Root canal obturating pointRoot canal obturating pointClass IIa
Root canal obturation kitRoot canal obturation kitClass I
Root canal post custom-madeRoot canal post custom-made
Root canal post custom-madeRoot canal post custom-madeClass I
Root canal post custom-madeRoot canal post custom-madeClass IIa
Root canal post custom-madeRoot canal post custom-madeClass IIb
Root canal post kitRoot canal post kit
Root canal post kitRoot canal post kitClass I
Root canal post kitRoot canal post kitClass IIa
Root canal post preformedRoot canal post preformed
Root canal post preformedRoot canal post preformedClass I
Root canal post preformedRoot canal post preformedClass IIa
Root canal post thread cutterRoot canal post thread cutterClass I
ROS proto-oncogene 1 receptor tyrosine kinase gene mutation/mRNA expression IVD kit nucleic acid technique (NAT)ROS proto-oncogene 1 receptor tyrosine kinase gene mutation/mRNA expression IVD kit nucleic acid technique (NAT)IVD General
Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayRoss River virus (RRV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Ross River virus (RRV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayRoss River virus (RRV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Ross River virus (RRV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Ross River virus (RRV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Rotary microtome IVDRotary microtome IVDClass A
Rotary microtome IVDRotary microtome IVDIVD General
Rotary/reciprocating endodontic file/rasp reusableRotary/reciprocating endodontic file/rasp reusableClass IIa
Rotary/reciprocating endodontic file/rasp single-useRotary/reciprocating endodontic file/rasp single-useClass IIa
Rotating hinged total knee prosthesisRotating hinged total knee prosthesis Conformity Assessment Certificate ExpiredClass III
Rotating hinged total knee prosthesisRotating hinged total knee prosthesis
Rotating hinged total knee prosthesisRotating hinged total knee prosthesisClass IIb
Rotating hinged total knee prosthesisRotating hinged total knee prosthesisClass III
Rotating pneumatic tourniquet systemRotating pneumatic tourniquet systemClass I
Rotation bed electricRotation bed electricClass I
Rotavirus antigen IVD controlRotavirus antigen IVD controlIVD General
Rotavirus antigen IVD kit chemiluminescent immunoassayRotavirus antigen IVD kit chemiluminescent immunoassayIVD General
Rotavirus antigen IVD kit enzyme immunoassay (EIA)Rotavirus antigen IVD kit enzyme immunoassay (EIA)IVD General
Rotavirus antigen IVD kit rapid agglutination clinicalRotavirus antigen IVD kit rapid agglutination clinicalIVD General
Rotavirus antigen IVD kit rapid ICT clinicalRotavirus antigen IVD kit rapid ICT clinicalIVD General
Rotavirus nucleic acid IVD kit nucleic acid technique (NAT)Rotavirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Rotavirus total antibody IVD controlRotavirus total antibody IVD controlIVD General
Rotavirus total antibody IVD reagentRotavirus total antibody IVD reagentIVD General
Roxithromycin susceptibility testing disc IVDRoxithromycin susceptibility testing disc IVDIVD General
Rubber dam clamp forcepsRubber dam clamp forcepsClass I
Rubber dam clampRubber dam clampClass I
Rubber dam frameRubber dam frameClass I
Rubber dam Hevea-latexRubber dam Hevea-latexClass I
Rubber dam Hevea-latexRubber dam Hevea-latexClass IIa
Rubber dam kitRubber dam kit
Rubber dam kitRubber dam kitClass I
Rubber dam non-latexRubber dam non-latexClass I
Rubber dam punchRubber dam punchClass I
Rubber dam stabilization cord non-latexRubber dam stabilization cord non-latexClass I
Rubberized sheetRubberized sheet Conformity Assessment Certificate ExpiredClass I
Rubella immunoglobulin G (IgG) antibody avidity index IVD controlRubella immunoglobulin G (IgG) antibody avidity index IVD controlIVD Annex II List B
Rubella virus antigen IVD kit enzyme immunoassay (EIA)Rubella virus antigen IVD kit enzyme immunoassay (EIA)IVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD calibratorRubella virus immunoglobulin G (IgG) antibody IVD calibratorIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD controlClass C
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD controlIVD General
Rubella virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Rubella virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Rubella virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Rubella virus immunoglobulin M (IgM) antibody IVD calibratorRubella virus immunoglobulin M (IgM) antibody IVD calibratorIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD controlRubella virus immunoglobulin M (IgM) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD controlRubella virus immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Rubella virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD Annex II List B
Rubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayRubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayRubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
S100-beta (S100-B) protein IVD calibratorS100-beta (S100-B) protein IVD calibratorIVD General
S100-beta (S100-B) protein IVD controlS100-beta (S100-B) protein IVD controlIVD General
S100-beta (S100-B) protein IVD kit chemiluminescent immunoassayS100-beta (S100-B) protein IVD kit chemiluminescent immunoassayIVD General
S100 calcium-binding protein A12 (S100A12) IVD kit enzyme immunoassay (EIA)S100 calcium-binding protein A12 (S100A12) IVD kit enzyme immunoassay (EIA)IVD General
S100 protein IVD antibodyS100 protein IVD antibodyClass C
S100 protein IVD antibodyS100 protein IVD antibodyIVD General
S100 protein IVD kit enzyme immunohistochemistryS100 protein IVD kit enzyme immunohistochemistryIVD General
Sabouraud dextrose fungal agar culture medium IVDSabouraud dextrose fungal agar culture medium IVDIVD General
Saccamanno solution IVDSaccamanno solution IVDClass A
Saccamanno solution IVDSaccamanno solution IVDIVD General
Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD controlSaccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD controlIVD General
Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA)Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA)IVD General
Saccharomyces cerevisiae immunoglobulin A (IgA)/IgG antibody IVD kit enzyme immunoassay (EIA)Saccharomyces cerevisiae immunoglobulin A (IgA)/IgG antibody IVD kit enzyme immunoassay (EIA)IVD General
Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD controlSaccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD controlIVD General
Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Saccharomyces cerevisiae total antibody IVD kit enzyme immunoassay (EIA)Saccharomyces cerevisiae total antibody IVD kit enzyme immunoassay (EIA)IVD General
Sacral plexus implantable incontinence-control electrical stimulation system electrodeSacral plexus implantable incontinence-control electrical stimulation system electrode Conformity Assessment Certificate Expired
Sacral plexus implantable incontinence-control electrical stimulation systemSacral plexus implantable incontinence-control electrical stimulation system
Sacral plexus implantable incontinence-control electrical stimulation systemSacral plexus implantable incontinence-control electrical stimulation systemClass I
Sacral plexus percutaneous incontinence-control electrical stimulation system electrodeSacral plexus percutaneous incontinence-control electrical stimulation system electrodeClass IIa
Sacral plexus percutaneous incontinence-control electrical stimulation system programmerSacral plexus percutaneous incontinence-control electrical stimulation system programmerClass IIb
Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generatorSacral plexus percutaneous incontinence-control electrical stimulation system pulse generatorClass IIb
Sacroiliac joint intra-articular arthrodesis implantSacroiliac joint intra-articular arthrodesis implantClass IIb
Sacroiliac joint transarticular fixation/arthrodesis implant coatedSacroiliac joint transarticular fixation/arthrodesis implant coatedClass IIb
Sacroiliac joint transarticular fixation/arthrodesis implant uncoated non-sterileSacroiliac joint transarticular fixation/arthrodesis implant uncoated non-sterileClass IIb
Sacroiliac joint transarticular fixation/arthrodesis implant uncoatedSacroiliac joint transarticular fixation/arthrodesis implant uncoatedClass IIb
Sacroiliac spine orthosis flexibleSacroiliac spine orthosis flexible
Sacroiliac spine orthosisSacroiliac spine orthosis
Sacroiliac spine orthosisSacroiliac spine orthosisClass I
Safety razor single-useSafety razor single-useClass I
Sal-like protein 4 (SALL4) IVD antibodySal-like protein 4 (SALL4) IVD antibodyIVD General
Salicylate IVD calibratorSalicylate IVD calibratorIVD General
Salicylate IVD kit enzyme immunoassay (EIA)Salicylate IVD kit enzyme immunoassay (EIA)IVD General
Salicylate IVD kit enzyme spectrophotometrySalicylate IVD kit enzyme spectrophotometryIVD General
Salicylate IVD kit spectrophotometrySalicylate IVD kit spectrophotometryIVD General
Salicylate IVD reagentSalicylate IVD reagentIVD General
Saline-filled breast implant unstructured smooth-surface Saline-filled breast implant unstructured smooth-surface Class III
Saline sodium citrate buffer IVDSaline sodium citrate buffer IVDClass A
Saline sodium citrate buffer IVDSaline sodium citrate buffer IVDIVD General
Saline suspension medium/diluent IVDSaline suspension medium/diluent IVDClass A
Saline suspension medium/diluent IVDSaline suspension medium/diluent IVDIVD General
Saliva absorbentSaliva absorbentClass I
Saliva collection mouthpiece IVDSaliva collection mouthpiece IVDClass A
Saliva collection mouthpiece IVDSaliva collection mouthpiece IVDIVD General
Saliva pH IVD kit rapid colorimetric clinicalSaliva pH IVD kit rapid colorimetric clinicalIVD General
Saliva quantification IVD kit spectrophotometrySaliva quantification IVD kit spectrophotometryIVD General
Saliva specimen extraction/dilution solution tartrazinSaliva specimen extraction/dilution solution tartrazinClass I
Salivary gland balloon catheterSalivary gland balloon catheterClass I
Salivary gland balloon catheterSalivary gland balloon catheterClass IIa
Salivary gland catheterSalivary gland catheterClass I
Salivary gland catheterSalivary gland catheterClass IIa
Salivary gland dilator single-useSalivary gland dilator single-useClass I
Salivary irrigation catheterSalivary irrigation catheterClass I
Salivary stone retrieval basketSalivary stone retrieval basketClass I
Salivary stone retrieval basketSalivary stone retrieval basketClass IIa
Salivation stimulation lozengeSalivation stimulation lozengeClass I
Saliva/oral specimen collection kit IVD home-useSaliva/oral specimen collection kit IVD home-useIVD General
Saliva/oral specimen collection kit no additiveSaliva/oral specimen collection kit no additiveClass I
Saliva/oral specimen collection kit no additiveSaliva/oral specimen collection kit no additiveIVD General
Salmonella paratyphi antigen IVD kit rapid ICT clinicalSalmonella paratyphi antigen IVD kit rapid ICT clinicalIVD General
Salmonella paratyphi antigen IVD reagentSalmonella paratyphi antigen IVD reagentIVD General
Salmonella paratyphi total antibody IVD kit agglutinationSalmonella paratyphi total antibody IVD kit agglutinationIVD General
Salmonella paratyphi total antibody IVD reagentSalmonella paratyphi total antibody IVD reagentIVD General
Salmonella typhi antigen IVD controlSalmonella typhi antigen IVD controlIVD General
Salmonella typhi antigen IVD kit agglutinationSalmonella typhi antigen IVD kit agglutinationIVD General
Salmonella typhi antigen IVD kit rapid ICT clinicalSalmonella typhi antigen IVD kit rapid ICT clinicalIVD General
Salmonella typhi antigen IVD reagentSalmonella typhi antigen IVD reagentIVD General
Salmonella typhi immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Salmonella typhi immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Salmonella typhi immunoglobulin G (IgG)/IgM antibody IVD reagentSalmonella typhi immunoglobulin G (IgG)/IgM antibody IVD reagentIVD General
Salmonella typhi total antibody IVD kit agglutinationSalmonella typhi total antibody IVD kit agglutinationIVD General
Salmonella typhi total antibody IVD kit enzyme immunoassay (EIA)Salmonella typhi total antibody IVD kit enzyme immunoassay (EIA)IVD General
Salmonella typhi total antibody IVD kit immunoblotSalmonella typhi total antibody IVD kit immunoblotIVD General
Salmonella typhi total antibody IVD reagentSalmonella typhi total antibody IVD reagentIVD General
Salmonella/Shigella species agar culture medium IVDSalmonella/Shigella species agar culture medium IVDIVD General
Salpingeal curetteSalpingeal curetteClass I
Salpingographic catheterSalpingographic catheterClass I
Sample transport for NA TestingSample transport for NA TestingIVD General
Sampling And Cell Collection Devices (Patient Contact - Not IVDDs)Sampling And Cell Collection Devices (Patient Contact - Not IVDDs)Class I
Sapovirus nucleic acid IVD kit nucleic acid technique (NAT)Sapovirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Sarcoglycan complex IVD antibodySarcoglycan complex IVD antibodyIVD General
SARS-CoV-1 antigen IVD reagentSARS-CoV-1 antigen IVD reagentIVD General
SARS-CoV-1 immunoglobulin G (IgG) antibody IVD reagentSARS-CoV-1 immunoglobulin G (IgG) antibody IVD reagentIVD General
SARS-CoV-1 immunoglobulin M (IgM) antibody IVD reagentSARS-CoV-1 immunoglobulin M (IgM) antibody IVD reagentIVD General