Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
High performance liquid chromatography analyser column IVDHigh performance liquid chromatography analyser column IVDIVD General
High performance liquid chromatography analyser IVD automatedHigh performance liquid chromatography analyser IVD automatedIVD General
High performance liquid chromatography analyser IVD semi-automatedHigh performance liquid chromatography analyser IVD semi-automatedClass A
High performance liquid chromatography analyser IVD semi-automatedHigh performance liquid chromatography analyser IVD semi-automatedIVD General
Hinged total elbow prosthesisHinged total elbow prosthesis Conformity Assessment Certificate ExpiredClass III
Hinged total elbow prosthesisHinged total elbow prosthesis
Hinged total elbow prosthesisHinged total elbow prosthesisClass IIb
Hinged total elbow prosthesisHinged total elbow prosthesisClass III
Hip-disarticulation prosthesisHip-disarticulation prosthesis
Hip hemiarthroplasty femur prosthesisHip hemiarthroplasty femur prosthesis
Hip hemiarthroplasty femur prosthesisHip hemiarthroplasty femur prosthesisClass IIb
Hip hemiarthroplasty femur prosthesisHip hemiarthroplasty femur prosthesisClass III
Hip internal fixation systemHip internal fixation system
Hip internal fixation systemHip internal fixation systemClass IIb
Hip internal fixation systemHip internal fixation systemClass III
Hip orthosisHip orthosis
Hip orthosisHip orthosisClass I
Hip prosthesis socket pusherHip prosthesis socket pusherClass I
Hip prosthesis socket pusherHip prosthesis socket pusherClass III
Hip protection trousersHip protection trousersClass I
Hip revision prosthesis trialHip revision prosthesis trial
Hip revision prosthesis trialHip revision prosthesis trialClass IIa
Hip unit prosthesisHip unit prosthesis
Hippurate hydrolase microbial reagent IVDHippurate hydrolase microbial reagent IVDClass A
Hippurate hydrolase microbial reagent IVDHippurate hydrolase microbial reagent IVDIVD General
Hip/knee continuous passive motion exerciserHip/knee continuous passive motion exerciserClass IIa
Hip/knee orthosisHip/knee orthosis
Hip/knee orthosisHip/knee orthosisClass I
Hip/knee/ankle/foot orthosisHip/knee/ankle/foot orthosis
Hip/knee/ankle/foot orthosisHip/knee/ankle/foot orthosisClass I
Histamine antibody IVD kit enzyme immunoassay (EIA)Histamine antibody IVD kit enzyme immunoassay (EIA)IVD General
Histological tissue cassette biopsy insert IVDHistological tissue cassette biopsy insert IVDClass A
Histological tissue cassette biopsy insert IVDHistological tissue cassette biopsy insert IVDIVD General
Histology tissue cassette IVD laboratory processingHistology tissue cassette IVD laboratory processingClass A
Histology tissue cassette IVD laboratory processingHistology tissue cassette IVD laboratory processingIVD General
Histology tissue processing reagent kit IVDHistology tissue processing reagent kit IVD Conformity Assessment Certificate ExpiredClass D – Companion Diagnostics
Histology tissue processing reagent kit IVDHistology tissue processing reagent kit IVDClass A
Histology tissue processing reagent kit IVDHistology tissue processing reagent kit IVDIVD General
Histology/cytology/microbiology image-analysis interpretive software IVDHistology/cytology/microbiology image-analysis interpretive software IVDClass C
Histology/cytology/microbiology image-analysis interpretive software IVDHistology/cytology/microbiology image-analysis interpretive software IVDIVD General
Histology/pathology manual tissue cutting set IVDHistology/pathology manual tissue cutting set IVDClass A
Histology/pathology manual tissue cutting set IVDHistology/pathology manual tissue cutting set IVDIVD General
Histology/pathology tissue cutting board IVDHistology/pathology tissue cutting board IVDIVD General
Histology/pathology tissue knife blade IVDHistology/pathology tissue knife blade IVDIVD General
Histology/pathology tissue knife handle IVDHistology/pathology tissue knife handle IVDIVD General
Histology/pathology tissue knife IVDHistology/pathology tissue knife IVDClass A
Histone antibody IVD controlHistone antibody IVD controlIVD General
Histone antibody IVD kit chemiluminescent immunoassayHistone antibody IVD kit chemiluminescent immunoassayIVD General
Histone antibody IVD kit enzyme immunoassay (EIA)Histone antibody IVD kit enzyme immunoassay (EIA)IVD General
Histone protein IVD antibodyHistone protein IVD antibodyIVD General
Histoplasma capsulatum antigen IVD controlHistoplasma capsulatum antigen IVD controlIVD General
Histoplasma capsulatum antigen IVD kit enzyme immunoassay (EIA)Histoplasma capsulatum antigen IVD kit enzyme immunoassay (EIA)IVD General
HIV1 antibody IVD controlHIV1 antibody IVD controlIVD Annex II List A
HIV1 antibody IVD kit immunoblotHIV1 antibody IVD kit immunoblotIVD Annex II List A
HIV1 antibody IVD kit rapid ICT clinicalHIV1 antibody IVD kit rapid ICT clinicalIVD Annex II List A
HIV1 antigen IVD controlHIV1 antigen IVD controlIVD Annex II List A
HIV1 antigen IVD kit enzyme immunoassay (EIA)HIV1 antigen IVD kit enzyme immunoassay (EIA)IVD Annex II List A
HIV1 antigen neutralization IVD kit enzyme immunoassay (EIA)HIV1 antigen neutralization IVD kit enzyme immunoassay (EIA)IVD Annex II List A
HIV1 genotyping IVD kit nucleic acid technique (NAT)HIV1 genotyping IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1 nucleic acid IVD calibratorHIV1 nucleic acid IVD calibratorIVD Annex II List A
HIV1 nucleic acid IVD controlHIV1 nucleic acid IVD controlIVD Annex II List A
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate ExpiredIVD Annex II List A
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1 nucleic acid IVD reagentHIV1 nucleic acid IVD reagentIVD Annex II List A
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlHIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlIVD Annex II List A
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate ExpiredIVD Annex II List A
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD reagentHIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD reagentIVD Annex II List A
HIV1/HIV2 antibody IVD controlHIV1/HIV2 antibody IVD controlIVD Annex II List A
HIV1/HIV2 antibody IVD kit chemiluminescent immunoassayHIV1/HIV2 antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 antibody IVD kit enzyme immunoassay (EIA)HIV1/HIV2 antibody IVD kit enzyme immunoassay (EIA)IVD Annex II List A
HIV1/HIV2 antibody IVD kit immunoblotHIV1/HIV2 antibody IVD kit immunoblotIVD Annex II List A
HIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testHIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testIVD Annex II List A
HIV1/HIV2 antibody IVD kit rapid ICT clinicalHIV1/HIV2 antibody IVD kit rapid ICT clinicalIVD Annex II List A
HIV1/HIV2 antibody IVD kit rapid ICT self-testingHIV1/HIV2 antibody IVD kit rapid ICT self-testingIVD Annex II List A
HIV1/HIV2 antibody IVD reagentHIV1/HIV2 antibody IVD reagentIVD Annex II List A
HIV1/HIV2 antigen IVD kit enzyme immunoassay (EIA)HIV1/HIV2 antigen IVD kit enzyme immunoassay (EIA)IVD Annex II List A
HIV1/HIV2 antigen/antibody IVD calibratorHIV1/HIV2 antigen/antibody IVD calibratorIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD controlHIV1/HIV2 antigen/antibody IVD controlIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayHIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA)HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA) Conformity Assessment Certificate ExpiredIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA)HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA)IVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit rapid ICT clinicalHIV1/HIV2 antigen/antibody IVD kit rapid ICT clinicalIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit rapid ICT clinicalHIV1/HIV2 antigen/antibody IVD kit rapid ICT clinicalIVD General
HIV1/HIV2 nucleic acid IVD controlHIV1/HIV2 nucleic acid IVD controlIVD Annex II List A
HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1/HIV2/Mycobacterium tuberculosis antibody IVD kit rapid ICT clinicalHIV1/HIV2/Mycobacterium tuberculosis antibody IVD kit rapid ICT clinicalIVD General
HIV1/HIV2/Mycobacterium tuberculosis antibody IVD reagentHIV1/HIV2/Mycobacterium tuberculosis antibody IVD reagentIVD General
HIV1/HIV2/Treponema pallidum antibody IVD kit rapid ICT clinicalHIV1/HIV2/Treponema pallidum antibody IVD kit rapid ICT clinicalIVD Annex II List A
HIV2 antibody IVD controlHIV2 antibody IVD controlIVD Annex II List A
HLA-B27 tissue typing IVD antibodyHLA-B27 tissue typing IVD antibodyIVD General
HLA-DR antigen nucleic acid tissue typing IVD controlHLA-DR antigen nucleic acid tissue typing IVD controlIVD Annex II List B
HLA-DR antigen tissue typing IVD antibodyHLA-DR antigen tissue typing IVD antibodyIVD General
HLA-DR antigen tissue typing IVD kit enzyme immunohistochemistryHLA-DR antigen tissue typing IVD kit enzyme immunohistochemistryIVD General
HLA class I antibody screening IVD kit enzyme immunoassay (EIA)HLA class I antibody screening IVD kit enzyme immunoassay (EIA)IVD General
HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)Class C
HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)IVD Annex II List B
HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)IVD General
HLA class I antigen tissue typing IVD kit multiplexHLA class I antigen tissue typing IVD kit multiplexIVD Annex II List B
HLA class I antigen tissue typing IVD kit multiplexHLA class I antigen tissue typing IVD kit multiplexIVD General
HLA class I & II antibody screening IVD controlHLA class I & II antibody screening IVD controlIVD General
HLA class I & II antibody screening IVD kit multiplexHLA class I & II antibody screening IVD kit multiplexIVD Annex II List B
HLA class I & II antibody screening IVD kit multiplexHLA class I & II antibody screening IVD kit multiplexIVD General
HLA class I & II antibody screening IVD reagentHLA class I & II antibody screening IVD reagentIVD General
HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)Class C
HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)IVD Annex II List B
HLA class I & II antigen nucleic acid tissue typing IVD reagentHLA class I & II antigen nucleic acid tissue typing IVD reagentClass C
HLA class I & II antigen nucleic acid tissue typing IVD reagentHLA class I & II antigen nucleic acid tissue typing IVD reagentIVD General
HLA class I & II antigen tissue typing IVD controlHLA class I & II antigen tissue typing IVD controlIVD Annex II List B
HLA class I & II antigen tissue typing IVD kit complement-dependent cytotoxicity (CDC)HLA class I & II antigen tissue typing IVD kit complement-dependent cytotoxicity (CDC)IVD Annex II List B
HLA class I & II antigen tissue typing IVD kit multiplexHLA class I & II antigen tissue typing IVD kit multiplexIVD Annex II List B
HLA class I & II antigen tissue typing IVD kit multiplexHLA class I & II antigen tissue typing IVD kit multiplexIVD General
HLA class II antigen identification IVD antibodyHLA class II antigen identification IVD antibodyIVD General
HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)Class C
HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)IVD Annex II List B
HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT)IVD General
HLA class II antigen tissue typing IVD kit multiplexHLA class II antigen tissue typing IVD kit multiplexIVD Annex II List B
HLA class II antigen tissue typing IVD kit multiplexHLA class II antigen tissue typing IVD kit multiplexIVD General
Hollow-fibre haemodialysis dialyser single-useHollow-fibre haemodialysis dialyser single-useClass IIb
Hollow-fibre haemodialysis dialyser single-useHollow-fibre haemodialysis dialyser single-useClass III
Holotranscobalamin (holoTC) IVD calibratorHolotranscobalamin (holoTC) IVD calibratorClass B
Holotranscobalamin (holoTC) IVD controlHolotranscobalamin (holoTC) IVD controlClass B
Holotranscobalamin (holoTC) IVD controlHolotranscobalamin (holoTC) IVD controlIVD General
Holotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayHolotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayClass B
Holotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayHolotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayIVD General
Home-use artificial insemination kitHome-use artificial insemination kitClass I
Home-use dental cementHome-use dental cement
Home-use dental cementHome-use dental cementClass I
Home-use dental cementHome-use dental cementClass IIa
Home-use dry eye therapy kitHome-use dry eye therapy kitClass I
Home-use magnetic neural stimulatorHome-use magnetic neural stimulatorClass IIa
Home-use sleep apnoea recording systemHome-use sleep apnoea recording systemClass I
Home-use sleep apnoea recording systemHome-use sleep apnoea recording systemClass IIa
Home-use transdermal medication applicatorHome-use transdermal medication applicatorClass I
Home-use transdermal medication applicatorHome-use transdermal medication applicatorClass III
Home-use/point-of-care coagulation analyser control IVDHome-use/point-of-care coagulation analyser control IVDIVD Devices for Self-Testing
Home blood collection kit IVDHome blood collection kit IVDClass A
Home blood collection kit IVDHome blood collection kit IVDIVD General
Home BPAP unitHome BPAP unitClass I
Home BPAP unitHome BPAP unitClass IIa
Home BPAP unitHome BPAP unitClass IIb
Home CPAP unitHome CPAP unitClass I
Home CPAP unitHome CPAP unitClass IIa
Home CPAP unitHome CPAP unitClass IIb
Home CPAP/BPAP washer/disinfectorHome CPAP/BPAP washer/disinfectorClass IIa
Home healthcare information system application softwareHome healthcare information system application softwareClass I
Home healthcare information system application softwareHome healthcare information system application softwareClass IIa
Home healthcare information system application softwareHome healthcare information system application softwareClass IIb
Home healthcare information systemHome healthcare information systemClass I
Home healthcare information systemHome healthcare information systemClass IIa
Home seizure monitoring systemHome seizure monitoring systemClass I
Home seizure monitoring systemHome seizure monitoring systemClass IIa
Homeobox protein CDX-2 IVD antibodyHomeobox protein CDX-2 IVD antibodyIVD General
Homocysteine IVD calibratorHomocysteine IVD calibratorIVD General
Homocysteine IVD controlHomocysteine IVD controlIVD General
Homocysteine IVD kit enzyme spectrophotometryHomocysteine IVD kit enzyme spectrophotometryIVD General
Homocysteine IVD kit liquid chromatographyHomocysteine IVD kit liquid chromatographyIVD General
Homocysteine IVD reagentHomocysteine IVD reagentIVD General
HomocysteineIVD kit chemiluminescent immunoassayHomocysteineIVD kit chemiluminescent immunoassayIVD General
Horizontal non-powered traction systemHorizontal non-powered traction systemClass I
Hospital-administration information systemHospital-administration information systemClass IIb
Hospital bed enclosure frameHospital bed enclosure frameClass I
Hospital Beds And Patient Positioning AidsHospital Beds And Patient Positioning AidsClass I
Hospital stretcher manualHospital stretcher manualClass I
Hospital stretcher poweredHospital stretcher poweredClass I
Hot therapy pack heating unitHot therapy pack heating unitClass I
Hot water bottleHot water bottleClass I
Hot/cold therapy pack reusableHot/cold therapy pack reusable
Hot/cold therapy pack reusableHot/cold therapy pack reusableClass I
Hot/cold therapy pack reusableHot/cold therapy pack reusableClass IIa
Hot/cold therapy pack single-useHot/cold therapy pack single-use Conformity Assessment Certificate ExpiredClass IIa
Hot/cold therapy pack single-useHot/cold therapy pack single-useClass I
Hot/cold therapy pack single-useHot/cold therapy pack single-useClass IIa
Hot/cold therapy systemHot/cold therapy systemClass I
House dust mite barrier bed mattress coverHouse dust mite barrier bed mattress coverClass I
HSV - NA ReagentsHSV - NA ReagentsIVD General
Hu antibody (anti-Hu) IVD reagentHu antibody (anti-Hu) IVD reagentIVD General
Human astrovirus antigen IVD kit rapid ICT clinicalHuman astrovirus antigen IVD kit rapid ICT clinicalIVD General
Human Chorionic Gonadotropin TotalHuman Chorionic Gonadotropin TotalIVD General
Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD calibratorHuman chorionic gonadotropin alpha-subunit (alpha-HCG) IVD calibratorIVD Devices for Self-Testing
Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD kit rapid ICT clinicalHuman chorionic gonadotropin alpha-subunit (alpha-HCG) IVD kit rapid ICT clinicalIVD Devices for Self-Testing
Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD kit rapid ICT clinicalHuman chorionic gonadotropin alpha-subunit (alpha-HCG) IVD kit rapid ICT clinicalIVD General
Human chorionic gonadotropin beta-core fragment IVD calibratorHuman chorionic gonadotropin beta-core fragment IVD calibratorIVD General
Human chorionic gonadotropin beta-core fragment IVD controlHuman chorionic gonadotropin beta-core fragment IVD controlIVD General
Human chorionic gonadotropin beta-core fragment IVD kit enzyme immunoassay (EIA)Human chorionic gonadotropin beta-core fragment IVD kit enzyme immunoassay (EIA)IVD General
Human chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinicalHuman chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinicalIVD Devices for Self-Testing
Human chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinicalHuman chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinicalIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD antibodyHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD antibodyIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD calibratorHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD calibratorIVD Annex II List B
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD calibratorHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD calibratorIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD controlHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD controlIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit agglutination rapidHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit agglutination rapidIVD Devices for Self-Testing
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit agglutination rapidHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit agglutination rapidIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayIVD Annex II List B
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit enzyme immunoassay (EIA)Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit enzyme immunoassay (EIA)IVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit enzyme immunohistochemistryHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit enzyme immunohistochemistryIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassayIVD Annex II List B
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassayIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapidHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapidIVD Devices for Self-Testing
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapidHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapidIVD General