Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Saliva collection mouthpiece IVDSaliva collection mouthpiece IVDIVD General
Saliva pH IVD kit colorimetric dipstick rapidSaliva pH IVD kit colorimetric dipstick rapidIVD 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 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
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 immunochromatographic test (ICT) rapidSalmonella paratyphi antigen IVD kit immunochromatographic test (ICT) rapidIVD 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 typhi antigen IVD kit agglutinationSalmonella typhi antigen IVD kit agglutinationIVD General
Salmonella typhi antigen IVD kit immunochromatographic test (ICT) rapidSalmonella typhi antigen IVD kit immunochromatographic test (ICT) rapidIVD 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 kit enzyme immunoassay (EIA)Salmonella typhi immunoglobulin G (IgG)/IgM 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 nucleic acid IVD controlSalmonella typhi nucleic acid IVD controlIVD 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 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
Sandfly fever virus nucleic acid IVD controlSandfly fever virus nucleic acid IVD controlIVD General
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 G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-1 immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-1 immunoglobulin M (IgM) antibody IVD reagentSARS-CoV-1 immunoglobulin M (IgM) antibody IVD reagentIVD General
SARS-CoV-1 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-1 nucleic acid IVD kit nucleic acid technique (NAT)IVD General
SARS-CoV-1/SARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) rapidSARS-CoV-1/SARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 antigen IVD calibratorSARS-CoV-2 antigen IVD calibratorIVD General
SARS-CoV-2 antigen IVD controlSARS-CoV-2 antigen IVD controlIVD General
SARS-CoV-2 antigen IVD kit chemiluminescent immunoassaySARS-CoV-2 antigen IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 antigen IVD kit enzyme immunoassay (EIA)SARS-CoV-2 antigen IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 antigen IVD kit fluorescent immunoassay rapidSARS-CoV-2 antigen IVD kit fluorescent immunoassay rapidIVD General
SARS-CoV-2 antigen IVD kit fluorescent immunoassaySARS-CoV-2 antigen IVD kit fluorescent immunoassayIVD General
SARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) rapidIVD Devices for Self-Testing
SARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) self-testingSARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) self-testingIVD Devices for Self-Testing
SARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) self-testingSARS-CoV-2 antigen IVD kit immunochromatographic test (ICT) self-testingIVD General
SARS-CoV-2 immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit agglutinationSARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit agglutinationIVD General
SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 immunoglobulin A (IgA)/IgM antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin A (IgA)/IgM antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin A (IgA)/IgM antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 immunoglobulin A (IgA)/IgM antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD calibratorSARS-CoV-2 immunoglobulin G (IgG) antibody IVD calibratorIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassaySARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit immunochromatographic test (ICT) self-testingSARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit immunochromatographic test (ICT) self-testingIVD Devices for Self-Testing
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD controlIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay rapidSARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay rapidIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassaySARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit immunochromatographic test (ICT) rapidIVD Devices for Self-Testing
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit microarraySARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit microarrayIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM/neutralizing antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 immunoglobulin G (IgG)/IgM/neutralizing antibody IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD calibratorSARS-CoV-2 immunoglobulin M (IgM) antibody IVD calibratorIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD controlSARS-CoV-2 immunoglobulin M (IgM) antibody IVD controlIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassaySARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayIVD General
SARS-CoV-2 neutralizing antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 neutralizing antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 neutralizing antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 neutralizing antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 neutralizing antibody IVD kit fluorescent immunoassay rapidSARS-CoV-2 neutralizing antibody IVD kit fluorescent immunoassay rapidIVD General
SARS-CoV-2 neutralizing antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 neutralizing antibody IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 neutralizing antibody IVD kit nephelometry/turbidimetrySARS-CoV-2 neutralizing antibody IVD kit nephelometry/turbidimetryIVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)IVD General
SARS-CoV-2 total antibody IVD calibratorSARS-CoV-2 total antibody IVD calibratorIVD General
SARS-CoV-2 total antibody IVD controlSARS-CoV-2 total antibody IVD controlIVD General
SARS-CoV-2 total antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 total antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA)IVD General
SARS-CoV-2 total antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 total antibody IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2 total antibody IVD kit magnetic immunoassay rapidSARS-CoV-2 total antibody IVD kit magnetic immunoassay rapidIVD General
SARS-CoV-2 total antibody IVD reagentSARS-CoV-2 total antibody IVD reagentIVD General
SARS-CoV-2 total/neutralizing antibody IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2 total/neutralizing antibody IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2/influenza A/B antigen IVD controlSARS-CoV-2/influenza A/B antigen IVD controlIVD General
SARS-CoV-2/influenza A/B antigen IVD kit immunochromatographic test (ICT) rapidSARS-CoV-2/influenza A/B antigen IVD kit immunochromatographic test (ICT) rapidIVD General
SARS-CoV-2/influenza A/B nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2/influenza A/B nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Sawing power tool attachment oscillatingSawing power tool attachment oscillatingClass IIa
Sawing power tool attachment reciprocatingSawing power tool attachment reciprocatingClass I
Sawing power tool attachment reciprocatingSawing power tool attachment reciprocatingClass IIa
Sawing power tool attachment sagittalSawing power tool attachment sagittalClass I
Sawing power tool attachment sagittalSawing power tool attachment sagittalClass IIa
Scalp clip applier reusableScalp clip applier reusableClass I
Scalp clip applier single-useScalp clip applier single-useClass IIa
Scalp clip forcepsScalp clip forcepsClass I
Scalp cooling systemScalp cooling systemClass IIa
Scalp haemostasis clip reusableScalp haemostasis clip reusableClass I
Scalp haemostasis clip reusableScalp haemostasis clip reusableClass IIa
Scalp haemostasis clip single-useScalp haemostasis clip single-useClass IIa
Scalp vein intravenous administration setScalp vein intravenous administration setClass IIa
Scalp wound clipScalp wound clipClass I
Scalp wound clipScalp wound clipClass IIa
Scalpel blade remover non-sterileScalpel blade remover non-sterileClass I
Scalpel blade remover sterileScalpel blade remover sterileClass I
Scalpel handle reusableScalpel handle reusableClass I
Scalpel handle reusableScalpel handle reusableClass IIa
Scalpel handle single-useScalpel handle single-useClass I
Scalpel handle single-useScalpel handle single-useClass IIa
Scalpel reusableScalpel reusableClass I
Scalpel reusableScalpel reusableClass III
Scalpel single-useScalpel single-use
Scalpel single-useScalpel single-useClass IIa
Scanning-laser ophthalmic imaging systemScanning-laser ophthalmic imaging systemClass IIa
Scanning-laser ophthalmoscope/retinal optical coherence tomography systemScanning-laser ophthalmoscope/retinal optical coherence tomography systemClass IIa
Scanning laser optical microscopeScanning laser optical microscopeClass IIa
Scar management dressing reusableScar management dressing reusable
Scar management dressing reusableScar management dressing reusableClass I
Scar management dressing reusableScar management dressing reusableClass IIa
Scar management dressing single-use non-sterileScar management dressing single-use non-sterile
Scar management dressing single-use non-sterileScar management dressing single-use non-sterileClass I
Scar management dressing single-use non-sterileScar management dressing single-use non-sterileClass IIa
Scar management dressing single-use sterileScar management dressing single-use sterileClass I
ScarifierScarifierClass IIb
Schirmer Tear Test (Sterile Product)Schirmer Tear Test (Sterile Product)Class I
Schirmer tear test stripSchirmer tear test stripClass I
Schirmer tear test stripSchirmer tear test stripClass IIa
Schistosoma mansoni immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Schistosoma mansoni immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Schistosoma species immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Schistosoma species immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Scintillation-counter radiation survey meterScintillation-counter radiation survey meterClass I
Scleral buckling device non-bioabsorbableScleral buckling device non-bioabsorbableClass IIb
Scleral expansion implant implantation toolScleral expansion implant implantation toolClass I
Scleral expansion implantScleral expansion implantClass IIb
Scleral expansion implantScleral expansion implantClass III
Scleral incision positioning frameScleral incision positioning frameClass I
Scleral marker reusableScleral marker reusableClass I
Scleral marker single-useScleral marker single-useClass I
Scleral marker single-useScleral marker single-useClass IIa
Scleral plug reusableScleral plug reusableClass I
Scleral plug single-useScleral plug single-useClass IIa
Scleral shellScleral shell
Scleral shellScleral shellClass I
Scleroderma-70 antibody kitScleroderma-70 antibody kitIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD calibratorScleroderma-70 antibody (anti-Scl-70) IVD calibratorIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD controlScleroderma-70 antibody (anti-Scl-70) IVD controlIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD kit chemiluminescent immunoassayScleroderma-70 antibody (anti-Scl-70) IVD kit chemiluminescent immunoassayIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD kit enzyme immunoassay (EIA)Scleroderma-70 antibody (anti-Scl-70) IVD kit enzyme immunoassay (EIA)IVD General
Scleroderma-70 antibody (anti-Scl-70) IVD kit fluorescent immunoassayScleroderma-70 antibody (anti-Scl-70) IVD kit fluorescent immunoassayIVD General
Sclerotherapy endoscopic needle single-useSclerotherapy endoscopic needle single-useClass IIa
Sclerotherapy foam preparation kitSclerotherapy foam preparation kitClass I
ScoliometerScoliometerClass I
Scope eyepiece attachmentScope eyepiece attachmentClass I
Screw-extraction orthopaedic reamer single-useScrew-extraction orthopaedic reamer single-useClass IIa
Screw endosteal dental implant one-pieceScrew endosteal dental implant one-piece
Screw endosteal dental implant one-pieceScrew endosteal dental implant one-pieceClass I
Screw endosteal dental implant one-pieceScrew endosteal dental implant one-pieceClass IIa
Screw endosteal dental implant one-pieceScrew endosteal dental implant one-pieceClass IIb
Screw endosteal dental implant two-pieceScrew endosteal dental implant two-piece Conformity Assessment Certificate ExpiredClass IIb
Screw endosteal dental implant two-pieceScrew endosteal dental implant two-piece
Screw endosteal dental implant two-pieceScrew endosteal dental implant two-pieceClass IIa
Screw endosteal dental implant two-pieceScrew endosteal dental implant two-pieceClass IIb
Screw extractor reusableScrew extractor reusableClass I
Screw extractor reusableScrew extractor reusableClass IIa
Screw extractor reusableScrew extractor reusableClass III
Screw extractor single-useScrew extractor single-useClass I
Screw extractor single-useScrew extractor single-useClass IIa
Screwing power tool attachmentScrewing power tool attachmentClass I
Screwing power tool attachmentScrewing power tool attachmentClass IIa
Screwing power tool attachmentScrewing power tool attachmentClass IIb
Scrotal supportScrotal supportClass I
Scrub suit single-useScrub suit single-useClass I
Sealing-cuff scrub suitSealing-cuff scrub suitClass I
Seasonal affective disorder phototherapy unitSeasonal affective disorder phototherapy unitClass I
Seasonal affective disorder phototherapy unitSeasonal affective disorder phototherapy unitClass IIa
Seat-to-seat mobility frameSeat-to-seat mobility frameClass I
Seat toilet panSeat toilet panClass I
Secondary batterySecondary battery
Secondary batterySecondary batteryClass I
Secondary batterySecondary batteryClass IIb
Secretion suction kitSecretion suction kitClass I
Secretion suction kitSecretion suction kitClass IIa
Secretion/excreta skin cleanserSecretion/excreta skin cleanserClass I
Secretion/excreta skin cleanserSecretion/excreta skin cleanserClass IIa
Seizure bite blockSeizure bite block
Seizure bite blockSeizure bite blockClass I
Selenite Salmonella species broth culture medium IVDSelenite Salmonella species broth culture medium IVDIVD General
Selenium IVD kit mass spectroscopySelenium IVD kit mass spectroscopyIVD General
Self-care monitoring/reporting softwareSelf-care monitoring/reporting softwareClass I
Self-care monitoring/reporting softwareSelf-care monitoring/reporting softwareClass IIa
Self-care monitoring/reporting softwareSelf-care monitoring/reporting softwareClass IIb
Self-expandable heart valve bioprosthesis collapsing tool single-useSelf-expandable heart valve bioprosthesis collapsing tool single-useClass I
Self-expandable heart valve prosthesis collapsing tool baseSelf-expandable heart valve prosthesis collapsing tool baseClass I
Self-expandable heart valve prosthesis post-dilation balloon catheterSelf-expandable heart valve prosthesis post-dilation balloon catheterClass IIa
Self-ligating orthodontic bracket open/close toolSelf-ligating orthodontic bracket open/close toolClass I
Self-ligating orthodontic bracketSelf-ligating orthodontic bracket Conformity Assessment Certificate ExpiredClass IIa