Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
Proctoscope single-useProctoscope single-useClass I
Proctoscope single-useProctoscope single-useClass IIa
Proctoscopes Anascopes And AccessoriesProctoscopes Anascopes And AccessoriesClass I
Professional BPAP/high-flow respiratory unitProfessional BPAP/high-flow respiratory unitClass IIb
Professional examination gown single-useProfessional examination gown single-useClass I
Professional high-flow respiratory unitProfessional high-flow respiratory unitClass IIa
Profiling And Therapeutic BedsProfiling And Therapeutic BedsClass I
Progastrin-releasing peptide (ProGRP) IVD calibratorProgastrin-releasing peptide (ProGRP) IVD calibratorIVD General
Progastrin-releasing peptide (ProGRP) IVD controlProgastrin-releasing peptide (ProGRP) IVD controlIVD General
Progastrin-releasing peptide (ProGRP) IVD kit chemiluminescent immunoassayProgastrin-releasing peptide (ProGRP) IVD kit chemiluminescent immunoassayIVD General
Progesterone IVD calibratorProgesterone IVD calibratorIVD General
Progesterone IVD controlProgesterone IVD controlIVD General
Progesterone IVD kit chemiluminescent immunoassayProgesterone IVD kit chemiluminescent immunoassayIVD General
Progesterone IVD kit enzyme immunoassay (EIA)Progesterone IVD kit enzyme immunoassay (EIA)IVD General
Progesterone IVD kit radioimmunoassayProgesterone IVD kit radioimmunoassayIVD General
Progesterone IVD reagentProgesterone IVD reagentIVD General
Progesterone receptor IVD antibodyProgesterone receptor IVD antibodyClass C
Progesterone receptor IVD antibodyProgesterone receptor IVD antibodyIVD General
Progesterone receptor IVD kit enzyme immunohistochemistryProgesterone receptor IVD kit enzyme immunohistochemistryIVD General
Programmable ambulation exoskeleton clinicalProgrammable ambulation exoskeleton clinicalClass IIa
Programmable ambulation exoskeleton home-useProgrammable ambulation exoskeleton home-useClass IIa
Programmable powered traction systemProgrammable powered traction systemClass IIa
Programmed death-1 (PD-1) IVD antibodyProgrammed death-1 (PD-1) IVD antibodyIVD General
Programmed death-ligand 1 (PD-L1) IVD antibodyProgrammed death-ligand 1 (PD-L1) IVD antibodyIVD General
Programmed death-ligand 1 (PD-L1) IVD controlProgrammed death-ligand 1 (PD-L1) IVD controlIVD General
Programmed death-ligand 1 (PD-L1) IVD kit enzyme immunohistochemistryProgrammed death-ligand 1 (PD-L1) IVD kit enzyme immunohistochemistryIVD General
Proinsulin IVD controlProinsulin IVD controlIVD General
Proinsulin IVD kit chemiluminescent immunoassayProinsulin IVD kit chemiluminescent immunoassayIVD General
Proinsulin IVD kit enzyme immunoassay (EIA)Proinsulin IVD kit enzyme immunoassay (EIA)IVD General
Prolactin IVD antibodyProlactin IVD antibodyIVD General
Prolactin IVD calibratorProlactin IVD calibratorIVD General
Prolactin IVD controlProlactin IVD controlIVD General
Prolactin IVD kit chemiluminescent immunoassayProlactin IVD kit chemiluminescent immunoassayIVD General
Prolactin IVD kit enzyme immunoassay (EIA)Prolactin IVD kit enzyme immunoassay (EIA)IVD General
Prolactin IVD kit fluorescent immunoassayProlactin IVD kit fluorescent immunoassayIVD General
Prolactin IVD kit immunochromatographic test (ICT) rapidProlactin IVD kit immunochromatographic test (ICT) rapidIVD General
Prolactin IVD kit radioimmunoassayProlactin IVD kit radioimmunoassayIVD General
Prolactin IVD reagentProlactin IVD reagentIVD General
Proliferating cell nuclear antigen (PCNA) antibody IVD kit enzyme immunoassay (EIA)Proliferating cell nuclear antigen (PCNA) antibody IVD kit enzyme immunoassay (EIA)IVD General
Proliferating cell nuclear antigen (PCNA) IVD antibodyProliferating cell nuclear antigen (PCNA) IVD antibodyClass B
Proliferating cell nuclear antigen (PCNA) IVD antibodyProliferating cell nuclear antigen (PCNA) IVD antibodyIVD General
Proliferating cell nuclear antigen (PCNA) IVD kit enzyme immunohistochemistryProliferating cell nuclear antigen (PCNA) IVD kit enzyme immunohistochemistryIVD General
Prone scooter boardProne scooter boardClass I
Prone scooter boardProne scooter boardClass IIa
Propoxyphene IVD calibratorPropoxyphene IVD calibratorIVD General
Propoxyphene IVD controlPropoxyphene IVD controlIVD General
Propoxyphene IVD kit enzyme immunoassay (EIA)Propoxyphene IVD kit enzyme immunoassay (EIA)IVD General
Propoxyphene/propoxyphene metabolite IVD kit immunochromatographic test (ICT) rapidPropoxyphene/propoxyphene metabolite IVD kit immunochromatographic test (ICT) rapidIVD General
Prostacyclin IVD kit radioimmunoassayProstacyclin IVD kit radioimmunoassayIVD General
Prostaglandin D2 synthase IVD kit nephelometry/turbidimetryProstaglandin D2 synthase IVD kit nephelometry/turbidimetryIVD General
Prostate-specific membrane antigen (PSMA) IVD antibodyProstate-specific membrane antigen (PSMA) IVD antibodyClass C
Prostate-specific membrane antigen (PSMA) IVD antibodyProstate-specific membrane antigen (PSMA) IVD antibodyIVD Annex II List B
Prostate-specific membrane antigen (PSMA) IVD antibodyProstate-specific membrane antigen (PSMA) IVD antibodyIVD General
Prostate brachytherapy system applicator manualProstate brachytherapy system applicator manual
Prostate brachytherapy system applicator manualProstate brachytherapy system applicator manualClass I
Prostate brachytherapy system applicator manualProstate brachytherapy system applicator manualClass IIa
Prostate brachytherapy system applicator remote-afterloadingProstate brachytherapy system applicator remote-afterloading
Prostate brachytherapy system applicator remote-afterloadingProstate brachytherapy system applicator remote-afterloadingClass IIa
Prostatic acid phosphatase (PAP) IVD antibodyProstatic acid phosphatase (PAP) IVD antibodyIVD General
Prostatic acid phosphatase (PAP) IVD calibratorProstatic acid phosphatase (PAP) IVD calibratorIVD General
Prostatic acid phosphatase (PAP) IVD controlProstatic acid phosphatase (PAP) IVD controlIVD General
Prostatic acid phosphatase (PAP) IVD kit chemiluminescent immunoassayProstatic acid phosphatase (PAP) IVD kit chemiluminescent immunoassayIVD General
Prostatic acid phosphatase (PAP) IVD kit enzyme immunoassay (EIA)Prostatic acid phosphatase (PAP) IVD kit enzyme immunoassay (EIA)IVD General
Prostatic acid phosphatase (PAP) IVD kit enzyme spectrophotometryProstatic acid phosphatase (PAP) IVD kit enzyme spectrophotometryIVD General
Prostatic acid phosphatase (PAP) IVD reagentProstatic acid phosphatase (PAP) IVD reagentIVD General
Prostatic retraction implantProstatic retraction implantClass IIb
Protease immunohaematology reagent IVDProtease immunohaematology reagent IVDIVD Annex II List B
Protease immunohaematology reagent IVDProtease immunohaematology reagent IVDIVD General
Protease IVD kit immunochromatographic test (ICT) rapidProtease IVD kit immunochromatographic test (ICT) rapidIVD General
Protective Films (Varnish)Protective Films (Varnish)Class I
Protective PowderProtective PowderClass I
Protein C IVD kit chromogenicProtein C IVD kit chromogenicIVD General
Protein C IVD kit clottingProtein C IVD kit clottingIVD General
Protein C IVD kit enzyme immunoassay (EIA)Protein C IVD kit enzyme immunoassay (EIA)IVD General
Protein C IVD kit fluorescent immunoassayProtein C IVD kit fluorescent immunoassayIVD General
Protein C IVD kit precipitation/immunodiffusionProtein C IVD kit precipitation/immunodiffusionIVD General
Protein C IVD reagentProtein C IVD reagentIVD General
Protein electrophoresis IVD controlProtein electrophoresis IVD controlIVD General
Protein electrophoresis IVD kit electrophoresisProtein electrophoresis IVD kit electrophoresisIVD General
Protein electrophoresis IVD reagentProtein electrophoresis IVD reagentIVD General
Protein gene product 9.5 (PGP9.5) IVD antibodyProtein gene product 9.5 (PGP9.5) IVD antibodyIVD General
Protein kinase B IVD antibodyProtein kinase B IVD antibodyIVD General
Protein S IVD antibodyProtein S IVD antibodyIVD General
Protein S IVD kit clottingProtein S IVD kit clottingIVD General
Protein S IVD kit enzyme immunoassay (EIA)Protein S IVD kit enzyme immunoassay (EIA)IVD General
Protein S IVD kit nephelometry/turbidimetryProtein S IVD kit nephelometry/turbidimetryIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD calibratorProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD calibratorIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD controlProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD controlIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit chemiluminescent immunoassayProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit chemiluminescent immunoassayIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit enzyme immunoassay (EIA)Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit enzyme immunoassay (EIA)IVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit fluorescent immunoassayProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit fluorescent immunoassayIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit multiplexProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit multiplexIVD General
Proteinase 3 IVD kit enzyme immunoassay (EIA)Proteinase 3 IVD kit enzyme immunoassay (EIA)IVD General
Prothrombin antibody (anti-prothrombin) IVD kit enzyme immunoassay (EIA)Prothrombin antibody (anti-prothrombin) IVD kit enzyme immunoassay (EIA)IVD General
Prothrombin fragment 1 + 2 IVD kit enzyme immunoassay (EIA)Prothrombin fragment 1 + 2 IVD kit enzyme immunoassay (EIA)IVD General
Prothrombin time (PT) IVD calibratorProthrombin time (PT) IVD calibratorIVD General
Prothrombin time (PT) IVD controlProthrombin time (PT) IVD controlIVD General
Prothrombin time (PT) IVD kit clotting rapidProthrombin time (PT) IVD kit clotting rapidIVD Devices for Self-Testing
Prothrombin time (PT) IVD kit clotting rapidProthrombin time (PT) IVD kit clotting rapidIVD General
Prothrombin time (PT) IVD kit clottingProthrombin time (PT) IVD kit clottingIVD General
Prothrombin time (PT) IVD reagentProthrombin time (PT) IVD reagentIVD Devices for Self-Testing
Prothrombin time (PT) IVD reagentProthrombin time (PT) IVD reagentIVD General
Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD antibodyProto-oncogene tyrosine-protein kinase ROS (ROS1) IVD antibodyIVD General
Proton therapy systemProton therapy systemClass IIb
Protoporphyrin IX IVD calibratorProtoporphyrin IX IVD calibratorIVD General
Protoporphyrin IX IVD reagentProtoporphyrin IX IVD reagentIVD General
Protruding ear correction implantProtruding ear correction implant
Proximal interphalangeal joint prosthesis modularProximal interphalangeal joint prosthesis modular Conformity Assessment Certificate ExpiredClass IIb
Proximal interphalangeal joint prosthesis modularProximal interphalangeal joint prosthesis modularClass IIb
Proximal interphalangeal joint prosthesis one-pieceProximal interphalangeal joint prosthesis one-pieceClass IIb
Pseudocholinesterase IVD controlPseudocholinesterase IVD controlIVD General
Pseudocholinesterase IVD kit enzyme spectrophotometryPseudocholinesterase IVD kit enzyme spectrophotometryIVD General
Pseudocholinesterase IVD reagentPseudocholinesterase IVD reagentIVD General
Pseudomonas aeruginosa nucleic acid IVD kit nucleic acid technique (NAT)Pseudomonas aeruginosa nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation systemPsychiatric-therapy/physical-therapy transcutaneous electrical stimulation systemClass IIa
Psychological assessment softwarePsychological assessment softwareClass I
Psychophysiological biofeedback systemPsychophysiological biofeedback systemClass I
Ptosis slingPtosis slingClass IIb
Public face mask single-usePublic face mask single-useClass I
Pulmonary artery balloon catheter standardPulmonary artery balloon catheter standard Conformity Assessment Certificate ExpiredClass III
Pulmonary artery balloon catheter standardPulmonary artery balloon catheter standardClass III
Pulmonary artery balloon catheter thermal dilutionPulmonary artery balloon catheter thermal dilution Conformity Assessment Certificate ExpiredClass III
Pulmonary artery balloon catheter thermal dilutionPulmonary artery balloon catheter thermal dilutionClass III
Pulmonary function analysis system adultPulmonary function analysis system adultClass I
Pulmonary function analysis system adultPulmonary function analysis system adultClass IIa
Pulmonary function testing filter/mouthpiecePulmonary function testing filter/mouthpieceClass I
Pulmonary function testing filter/mouthpiecePulmonary function testing filter/mouthpieceClass IIa
Pulmonary function testing kitPulmonary function testing kit
Pulmonary function testing kitPulmonary function testing kitClass IIa
Pulmonary function testing nasal maskPulmonary function testing nasal maskClass I
Pulmonary function valvePulmonary function valveClass IIa
Pulmonary heart valve bioprosthesisPulmonary heart valve bioprosthesisClass III
Pulmonary resuscitator manual reusablePulmonary resuscitator manual reusableClass IIa
Pulmonary resuscitator manual single-usePulmonary resuscitator manual single-useClass I
Pulmonary resuscitator manual single-usePulmonary resuscitator manual single-useClass IIa
Pulmonary resuscitator pneumatic reusablePulmonary resuscitator pneumatic reusableClass IIa
Pulmonary resuscitator pneumatic reusablePulmonary resuscitator pneumatic reusableClass IIb
Pulmonary resuscitator pneumatic single-usePulmonary resuscitator pneumatic single-useClass IIa
Pulmonary resuscitator pneumatic single-usePulmonary resuscitator pneumatic single-useClass IIb
Pulmonary sound analysis systemPulmonary sound analysis systemClass IIa
Pulmonary transcatheter heart valve bioprosthesisPulmonary transcatheter heart valve bioprosthesisClass III
Pulse Co-oximeter probe reusablePulse Co-oximeter probe reusableClass IIb
Pulse Co-oximeter probe single-usePulse Co-oximeter probe single-useClass IIb
Pulse Co-oximeterPulse Co-oximeterClass IIb
Pulse oximeter line-poweredPulse oximeter line-powered Conformity Assessment Certificate ExpiredClass IIa
Pulse oximeter line-poweredPulse oximeter line-poweredClass IIa
Pulse oximeter line-poweredPulse oximeter line-poweredClass IIb
Pulse oximeter probe reprocessedPulse oximeter probe reprocessedClass IIb
Pulse oximeter probe reusablePulse oximeter probe reusableClass I
Pulse oximeter probe reusablePulse oximeter probe reusableClass IIa
Pulse oximeter probe reusablePulse oximeter probe reusableClass IIb
Pulse oximeter probe single-usePulse oximeter probe single-useClass I
Pulse oximeter probe single-usePulse oximeter probe single-useClass IIa
Pulse oximeter probe single-usePulse oximeter probe single-useClass IIb
Pulse oximeter probe/processorPulse oximeter probe/processorClass IIb
Pulse oximeterPulse oximeter
Pulse oximeterPulse oximeterClass IIa
Pulse oximeterPulse oximeterClass IIb
Pulse oximetry telemetric monitoring systemPulse oximetry telemetric monitoring systemClass IIa
Pulsed signal therapy system extremity coilPulsed signal therapy system extremity coilClass IIa
Pulsed signal therapy system tinnitus applicatorPulsed signal therapy system tinnitus applicatorClass IIa
PupillographPupillograph Conformity Assessment Certificate ExpiredClass IIa
PupillographPupillographClass I
Pure-tone audiometerPure-tone audiometerClass I
Pure-tone audiometerPure-tone audiometerClass IIa
Pure wool burn sheetPure wool burn sheetClass IIb
Pure wool joint insulatorPure wool joint insulatorClass I
Pure wool neck/shoulder insulatorPure wool neck/shoulder insulatorClass I
PU.1 transcription factor IVD antibodyPU.1 transcription factor IVD antibodyIVD General
Pylorus clampPylorus clampClass I
Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD kit colorimetric rapidPyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD kit colorimetric rapidIVD General
Pyrrolidonyl arylamidase (PYR) activity IVD kit colorimetric rapidPyrrolidonyl arylamidase (PYR) activity IVD kit colorimetric rapidIVD General
Pyrrolidonyl arylamidase (PYR) microbial reagent IVDPyrrolidonyl arylamidase (PYR) microbial reagent IVDIVD General
Pyruvate IVD reagentPyruvate IVD reagentIVD General
Pyruvate kinase M2 (PKM2) IVD controlPyruvate kinase M2 (PKM2) IVD controlIVD General
Pyruvate kinase M2 (PKM2) IVD kit enzyme spectrophotometryPyruvate kinase M2 (PKM2) IVD kit enzyme spectrophotometryIVD General
Pyruvate kinase M2 (PKM2) IVD reagentPyruvate kinase M2 (PKM2) IVD reagentIVD General
Quadriceps board exerciserQuadriceps board exerciserClass I
Quaternary ammonium compound device disinfectant/sterilant test stripQuaternary ammonium compound device disinfectant/sterilant test stripClass I
Quetiapine IVD reagentQuetiapine IVD reagentIVD General
Quetiapine therapeutic drug monitoring IVD reagentQuetiapine therapeutic drug monitoring IVD reagentIVD General
Quinidine therapeutic drug monitoring IVD calibratorQuinidine therapeutic drug monitoring IVD calibratorIVD General
Quinidine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Quinidine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Quinidine therapeuticdrug monitoringIVD kitnephelometry/turbidimetryQuinidine therapeuticdrug monitoringIVD kitnephelometry/turbidimetryIVD General
Quinupristin/dalfopristin susceptibility testing disc IVDQuinupristin/dalfopristin susceptibility testing disc IVDIVD General
Rabies virus antigen IVD antibodyRabies virus antigen IVD antibodyIVD General
Radial artery compression deviceRadial artery compression deviceClass I
Radial artery compression deviceRadial artery compression deviceClass IIa
Radial surgical retractor seal capRadial surgical retractor seal capClass IIa
Radial surgical retractorRadial surgical retractorClass I
Radial surgical retractorRadial surgical retractorClass IIa
Radiation-shielding procedure preparation glove/mittenRadiation-shielding procedure preparation glove/mittenClass I
Radiation attenuating Hevea-latex surgical/procedural gloveRadiation attenuating Hevea-latex surgical/procedural gloveClass IIa
Radiation attenuating polyisoprene surgical/procedural gloveRadiation attenuating polyisoprene surgical/procedural gloveClass IIa
Radiation blood/fluid warmerRadiation blood/fluid warmer
Radiation condenser R-meterRadiation condenser R-meterClass I
Radiation electrometerRadiation electrometerClass I
Radiation electrometerRadiation electrometerClass IIb
Radiation shielding apron rackRadiation shielding apron rackClass I
Radiation shielding apronRadiation shielding apronClass I