Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
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 clottingProthrombin time (PT) IVD kit clottingClass C
Prothrombin time (PT) IVD kit clottingProthrombin time (PT) IVD kit clottingIVD General
Prothrombin time (PT) IVD kit rapid clotting clinicalProthrombin time (PT) IVD kit rapid clotting clinicalIVD Devices for Self-Testing
Prothrombin time (PT) IVD kit rapid clotting clinicalProthrombin time (PT) IVD kit rapid clotting clinicalIVD 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 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Pseudomonas aeruginosa immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD 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 software
Psychological assessment softwarePsychological assessment softwareClass I
Psychophysiological biofeedback systemPsychophysiological biofeedback system
Psychophysiological biofeedback systemPsychophysiological biofeedback systemClass I
Psychophysiological biofeedback systemPsychophysiological biofeedback systemClass IIa
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 reusable Conformity Assessment Certificate ExpiredClass IIa
Pulmonary resuscitator manual reusablePulmonary resuscitator manual reusableClass IIa
Pulmonary resuscitator manual single-usePulmonary resuscitator manual single-use Conformity Assessment Certificate ExpiredClass 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 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 reusable Conformity Assessment Certificate ExpiredClass 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 Conformity Assessment Certificate ExpiredClass 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
PupillographPupillographClass IIa
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
Pure wool rehabilitation boot/slipperPure wool rehabilitation boot/slipper
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 rapid colorimetric clinicalPyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD kit rapid colorimetric clinicalIVD General
Pyrrolidonyl arylamidase (PYR) activity IVD kit rapid colorimetric clinicalPyrrolidonyl arylamidase (PYR) activity IVD kit rapid colorimetric clinicalIVD General
Pyrrolidonyl arylamidase (PYR) microbial reagent IVDPyrrolidonyl arylamidase (PYR) microbial reagent IVDClass A
Pyrrolidonyl arylamidase (PYR) microbial reagent IVDPyrrolidonyl arylamidase (PYR) microbial reagent IVDIVD 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 kit liquid chromatographyQuetiapine IVD kit liquid chromatographyIVD General
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
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
Radiation shielding collarRadiation shielding collarClass I
Radiation shielding container general-purposeRadiation shielding container general-purpose
Radiation shielding container general-purposeRadiation shielding container general-purposeClass I
Radiation shielding curtainRadiation shielding curtainClass I
Radiation shielding goggles/spectaclesRadiation shielding goggles/spectaclesClass I
Radiation shielding panel fixedRadiation shielding panel fixedClass I
Radiation shielding panel portable/mobileRadiation shielding panel portable/mobileClass I
Radiation therapy beam block materialRadiation therapy beam block material
Radiation therapy bolus reusableRadiation therapy bolus reusableClass I
Radiation therapy bolus single-useRadiation therapy bolus single-useClass I
Radiation therapy digital imagerRadiation therapy digital imagerClass IIb
Radiation therapy invasive marker lesion localization systemRadiation therapy invasive marker lesion localization systemClass IIb
Radiation therapy lesion localization urethral catheter planningRadiation therapy lesion localization urethral catheter planningClass IIa
Radiation therapy lesion localization urethral catheter proceduralRadiation therapy lesion localization urethral catheter proceduralClass IIa
Radiation therapy softwareRadiation therapy softwareClass I
Radiation therapy softwareRadiation therapy softwareClass IIb
Radiation therapy treatment planning positioning kitRadiation therapy treatment planning positioning kitClass I
Radiation therapy treatment planning workstationRadiation therapy treatment planning workstationClass IIb
Radiation therapy treatment record/verify systemRadiation therapy treatment record/verify systemClass IIb
Radiation/mechanical corneal shield reusableRadiation/mechanical corneal shield reusableClass I
Radiation/mechanical corneal shield single-useRadiation/mechanical corneal shield single-useClass I
Radio-frequency ablation systemRadio-frequency ablation systemClass I
Radio-frequency ablation systemRadio-frequency ablation systemClass IIa
Radio-frequency ablation systemRadio-frequency ablation systemClass IIb
Radio-frequency ablation systemRadio-frequency ablation systemClass III
Radio-frequency fat liquefaction systemRadio-frequency fat liquefaction systemClass IIb
Radio-frequency hyperhidrosis treatment/injection system needle electrodeRadio-frequency hyperhidrosis treatment/injection system needle electrodeClass IIa
Radio-frequency hyperhidrosis treatment/injection systemRadio-frequency hyperhidrosis treatment/injection systemClass IIb
Radio-frequency identification readerRadio-frequency identification readerClass I
Radio-frequency skin contouring system applicator monopolarRadio-frequency skin contouring system applicator monopolar Conformity Assessment Certificate ExpiredClass IIa
Radio-frequency skin contouring system applicator monopolarRadio-frequency skin contouring system applicator monopolarClass I
Radio-frequency skin contouring system applicator monopolarRadio-frequency skin contouring system applicator monopolarClass IIb
Radio-frequency skin contouring system applicator tipRadio-frequency skin contouring system applicator tipClass IIa
Radio-frequency skin contouring system applicator tipRadio-frequency skin contouring system applicator tipClass IIb
Radio-frequency skin contouring system electrode returnRadio-frequency skin contouring system electrode return Conformity Assessment Certificate ExpiredClass IIa
Radio-frequency skin contouring system generatorRadio-frequency skin contouring system generator Conformity Assessment Certificate ExpiredClass IIa
Radio-frequency skin contouring systemRadio-frequency skin contouring systemClass I
Radio-frequency skin contouring systemRadio-frequency skin contouring systemClass IIa
Radio-frequency skin contouring systemRadio-frequency skin contouring systemClass IIb
Radio-frequency skin surface treatment system applicatorRadio-frequency skin surface treatment system applicatorClass IIa
Radio-frequency skin surface treatment system applicatorRadio-frequency skin surface treatment system applicatorClass IIb
Radio-frequency skin surface treatment systemRadio-frequency skin surface treatment systemClass IIa
Radio-frequency skin surface treatment systemRadio-frequency skin surface treatment systemClass IIb
Radioaerosol administration radiation shieldRadioaerosol administration radiation shieldClass I
Radiographic Film Processing ChemicalsRadiographic Film Processing ChemicalsClass I
Radiographic film view box poweredRadiographic film view box poweredClass I
Radiographic image marker automaticRadiographic image marker automaticClass I
Radiographic image marker manualRadiographic image marker manual
Radiographic image marker manualRadiographic image marker manualClass I
Radiographic procedure tubingRadiographic procedure tubingClass IIa
Radiographic stretcherRadiographic stretcherClass I
Radiographic test patternRadiographic test patternClass I
Radioimmunoassay analyser IVD automated/semi-automatedRadioimmunoassay analyser IVD automated/semi-automatedClass A
Radioisotope calibration systemRadioisotope calibration systemClass I
Radiological arm/leg positionerRadiological arm/leg positionerClass I
Radiological breast positioner non-wearableRadiological breast positioner non-wearableClass I
Radiological breast positioner wearableRadiological breast positioner wearableClass I
Radiological chest positionerRadiological chest positionerClass I
Radiological general body-part positionerRadiological general body-part positionerClass I
Radiological general body-part positionerRadiological general body-part positionerClass IIa
Radiological headrestRadiological headrestClass I
Radiological head/neck positioning mouthpieceRadiological head/neck positioning mouthpiece
Radiological head/neck positioning mouthpieceRadiological head/neck positioning mouthpieceClass I
Radiological imaging system transport kitRadiological imaging system transport kitClass IIa
Radiological pelvis positionerRadiological pelvis positionerClass I
Radiological video camera patient positioning/tracking systemRadiological video camera patient positioning/tracking systemClass I
Radiological video camera patient positioning/tracking systemRadiological video camera patient positioning/tracking systemClass IIb
Radiological whole-body positionerRadiological whole-body positionerClass I
Radiological whole-body positionerRadiological whole-body positionerClass IIb
Radiology DICOM image processing application softwareRadiology DICOM image processing application software
Radiology DICOM image processing application softwareRadiology DICOM image processing application softwareClass I
Radiology DICOM image processing application softwareRadiology DICOM image processing application softwareClass IIa
Radiology DICOM image processing application softwareRadiology DICOM image processing application softwareClass IIb
Radiology information system application softwareRadiology information system application softwareClass I
Radiology information system application softwareRadiology information system application softwareClass IIa
Radiology information system application softwareRadiology information system application softwareClass IIb
Radiology information systemRadiology information systemClass I
Radiology PACS softwareRadiology PACS software
Radiology PACS softwareRadiology PACS softwareClass I
Radiology PACS softwareRadiology PACS softwareClass IIa
Radiology PACS softwareRadiology PACS softwareClass IIb