Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
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)IVD Annex II List A
HIV1/HIV2 antibody IVD, controlHIV1/HIV2 antibody IVD, controlIVD 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, immunochromatographic test (ICT), rapidHIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapidIVD 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)IVD Annex II List A
HIV1/HIV2 antigen/antibody IVD, kit, immunochromatographic test (ICT), rapidHIV1/HIV2 antigen/antibody IVD, kit, immunochromatographic test (ICT), rapidIVD Annex II List A
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, immunochromatographic test (ICT), rapidHIV1/HIV2/Mycobacterium tuberculosis antibody IVD, kit, immunochromatographic test (ICT), rapidIVD General
HIV1/HIV2/Treponema pallidum antibody IVD, kit, immunochromatographic test (ICT), rapidHIV1/HIV2/Treponema pallidum antibody IVD, kit, immunochromatographic test (ICT), rapidIVD Annex II List A
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)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 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)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, reagentIVD Annex II List B
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 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 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
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 sleep apnoea recording systemHome-use sleep apnoea recording system
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 III
Home alert systemHome alert systemClass I
Home blood collection kit IVDHome blood collection kit IVDIVD General
Home blood collection kitHome blood collection kit
Home blood collection kitHome blood collection kitIVD General
Home BPAP unitHome BPAP unitClass IIa
Home BPAP unitHome BPAP unitClass IIb
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 Insemination KitHome Insemination Kit
Home seizure monitoring systemHome seizure monitoring systemClass I
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, reagentHomocysteine IVD, reagentIVD General
Homocysteine?IVD, kit, chemiluminescent immunoassayHomocysteine?IVD, kit, chemiluminescent immunoassayIVD General
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 and Cold PacksHot and Cold PacksClass I
Hot/cold therapy pack, reusableHot/cold therapy pack, reusable
Hot/cold therapy pack, reusableHot/cold therapy pack, reusableClass I
Hot/cold therapy pack, single-useHot/cold therapy pack, single-useClass I
Hot/cold therapy pack, single-useHot/cold therapy pack, single-useClass IIa
House dust mite barrier bed mattress coverHouse dust mite barrier bed mattress cover
House dust mite barrier duvet coverHouse dust mite barrier duvet coverClass I
House dust mite barrier pillowcaseHouse dust mite barrier pillowcaseClass I
Human astrovirus antigen IVD, kit, immunochromatographic test (ICT), rapidHuman astrovirus antigen IVD, kit, immunochromatographic test (ICT), rapidIVD 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 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, 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, 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, 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, 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, radioimmunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, radioimmunoassayIVD General
Human epididymis protein 4 (HE4) IVD, calibratorHuman epididymis protein 4 (HE4) IVD, calibratorIVD General
Human epididymis protein 4 (HE4) IVD, controlHuman epididymis protein 4 (HE4) IVD, controlIVD General
Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassayHuman epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassayIVD General
Human genomic analysis interpretive softwareHuman genomic analysis interpretive softwareIVD Annex II List B
Human genomic analysis interpretive softwareHuman genomic analysis interpretive softwareIVD General
Human growth hormone (HGH) IVD, antibodyHuman growth hormone (HGH) IVD, antibodyIVD General
Human herpesvirus 6 (HHV6) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayHuman herpesvirus 6 (HHV6) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Human herpesvirus 7 (HHV7) nucleic acid IVD, kit, nucleic acid technique (NAT)Human herpesvirus 7 (HHV7) nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Human herpesvirus 8 (HHV8) antigen IVD, antibodyHuman herpesvirus 8 (HHV8) antigen IVD, antibodyIVD General
Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Human immunoglobulin A (IgA) caprine conjugate antibody reagent IVDHuman immunoglobulin A (IgA) caprine conjugate antibody reagent IVDIVD General
Human immunoglobulin G (IgG) caprine conjugate antibody reagent IVDHuman immunoglobulin G (IgG) caprine conjugate antibody reagent IVDIVD General
Human metapneumovirus (hMPV) antigen IVD, controlHuman metapneumovirus (hMPV) antigen IVD, controlIVD General
Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Human papillomavirus (HPV) nucleic acid IVD, controlHuman papillomavirus (HPV) nucleic acid IVD, controlIVD General
Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Human papillomavirus (HPV) nucleic acid IVD, probeHuman papillomavirus (HPV) nucleic acid IVD, probeIVD General
Human papillomavirus (HPV) nucleic acid IVD, reagentHuman papillomavirus (HPV) nucleic acid IVD, reagentIVD General
Human parainfluenza virus 1 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayHuman parainfluenza virus 1 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
Human parainfluenza virus 2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayHuman parainfluenza virus 2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
Human parainfluenza virus 3 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayHuman parainfluenza virus 3 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
Human parechovirus (HPeV) nucleic acid IVD, kit, nucleic acid technique (NAT)Human parechovirus (HPeV) nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Human placental alkaline phosphatase (hPLAP) IVD, antibodyHuman placental alkaline phosphatase (hPLAP) IVD, antibodyIVD General
Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)IVD General
Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, multiplexHuman platelet antigen (HPA) multiple antibody screening/identification IVD, kit, multiplexIVD General
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, calibratorHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, calibratorIVD Annex II List A
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, controlHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, controlIVD Annex II List A
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassayHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassayIVD Annex II List A
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)IVD Annex II List A
Human T-cell lymphotrophic virus 2 (HTLV2) nucleic acid IVD, controlHuman T-cell lymphotrophic virus 2 (HTLV2) nucleic acid IVD, controlIVD Annex II List A
Humeral-rotation prosthesisHumeral-rotation prosthesis
Humeral body extension prosthesis trialHumeral body extension prosthesis trial
Humeral body extension prosthesis trialHumeral body extension prosthesis trialClass IIa
Humeral body extension prosthesisHumeral body extension prosthesis
Humeral body extension prosthesisHumeral body extension prosthesisClass III
Humeral body prosthesis trialHumeral body prosthesis trial
Humeral body prosthesis trialHumeral body prosthesis trialClass I
Humeral body prosthesis trialHumeral body prosthesis trialClass IIa
Humeral centering sleeveHumeral centering sleeve
Humeral centering sleeveHumeral centering sleeveClass IIb
Humeral centering sleeveHumeral centering sleeveClass III
Humeral head prosthesis trial, reusableHumeral head prosthesis trial, reusable
Humeral head prosthesis trial, reusableHumeral head prosthesis trial, reusableClass I
Humeral head prosthesis trial, reusableHumeral head prosthesis trial, reusableClass IIa
Humeral head prosthesis trial, single-useHumeral head prosthesis trial, single-use
Humeral head spacer prosthesis trialHumeral head spacer prosthesis trial
Humeral head spacer prosthesis trialHumeral head spacer prosthesis trialClass IIa
Humeral head spacerHumeral head spacer
Humeral head spacerHumeral head spacerClass III
Humeral metaphyseal anchorHumeral metaphyseal anchor
Humeral metaphyseal anchorHumeral metaphyseal anchorClass III
Humeral stem extension locking ringHumeral stem extension locking ring
Humeral stem extension locking ringHumeral stem extension locking ringClass III
Humeral stem extension prosthesis trialHumeral stem extension prosthesis trial
Humeral stem extension prosthesis trialHumeral stem extension prosthesis trialClass IIa
Humeral stem extension prosthesisHumeral stem extension prosthesis
Humeral stem extension prosthesisHumeral stem extension prosthesisClass III
Humeral stem prosthesis trialHumeral stem prosthesis trial
Humeral stem prosthesis trialHumeral stem prosthesis trialClass IIa
Humerus nail, non-sterileHumerus nail, non-sterile
Humerus nail, non-sterileHumerus nail, non-sterileClass IIb
Humerus nail, sterileHumerus nail, sterile
Humerus nail, sterileHumerus nail, sterileClass IIb
Humidified oxygen administration setHumidified oxygen administration setClass IIa
Hybrid corrective contact lens, custom-madeHybrid corrective contact lens, custom-made
Hybrid corrective contact lens, custom-madeHybrid corrective contact lens, custom-madeClass IIa
Hybrid corrective contact lens, non-customizedHybrid corrective contact lens, non-customizedClass IIa
Hydraulic male urinary incontinence treatment system tubingHydraulic male urinary incontinence treatment system tubingClass IIb
Hydraulic male urinary incontinence treatment systemHydraulic male urinary incontinence treatment systemClass IIb
Hydraulic/pneumatic external ankle-foot prosthesisHydraulic/pneumatic external ankle-foot prosthesisClass I
Hydraulic/pneumatic external knee prosthesisHydraulic/pneumatic external knee prosthesisClass I
Hydrogen breath analyserHydrogen breath analyserClass I
Hydrogen peroxide device disinfectantHydrogen peroxide device disinfectantClass IIb
Hydrogen peroxide device disinfectant/sterilant test stripHydrogen peroxide device disinfectant/sterilant test stripClass I
Hydrogen peroxide device sterilantHydrogen peroxide device sterilantClass IIb
Hydrogen peroxide gas sterilizerHydrogen peroxide gas sterilizerClass IIb
Hydrophobic-barrier otic solutionHydrophobic-barrier otic solutionClass I
Hydrophobic Luer filter, sterileHydrophobic Luer filter, sterileClass I
Hydrophobic Luer filter, sterileHydrophobic Luer filter, sterileClass IIa
Hydrotherapy bath/tankHydrotherapy bath/tankClass I
Hydrotherapy bath/tankHydrotherapy bath/tankClass IIa
Hydrotherapy treadmillHydrotherapy treadmill
Hygiene apron, single-useHygiene apron, single-useClass I
Hygroscopic cervical dilatorHygroscopic cervical dilatorClass IIa
Hygroscopic dental cementHygroscopic dental cementClass IIa
Hyperhidrosis iontophoresis systemHyperhidrosis iontophoresis systemClass IIa
Hyperthermia system gantryHyperthermia system gantryClass IIb
Hypnotherapy virtual reality softwareHypnotherapy virtual reality softwareClass I
Hypoallergenic Double Sided Sticky Patch ? Used for adhering medical devices to the skinHypoallergenic Double Sided Sticky Patch ? Used for adhering medical devices to the skinClass I
Hypoallergenic skin adhesive tapeHypoallergenic skin adhesive tape
Hypoallergenic skin adhesive tapeHypoallergenic skin adhesive tapeClass I
Hypoallergenic skin adhesive tapeHypoallergenic skin adhesive tapeClass IIb
Hypodermal tissue reconstructive material, synthetic polymer, non-bioabsorbableHypodermal tissue reconstructive material, synthetic polymer, non-bioabsorbableClass IIb
Hypodermic-needle, single-useHypodermic-needle, single-useClass IIa
Hypodermic needle, single-useHypodermic needle, single-use
Hypodermic needle, single-useHypodermic needle, single-useClass IIa
Hypothermia-prevention capHypothermia-prevention capClass I
Hysterectomy scissorsHysterectomy scissorsClass I
Hysteroscopic irrigation/insufflation systemHysteroscopic irrigation/insufflation systemClass I
Hysteroscopic irrigation/insufflation systemHysteroscopic irrigation/insufflation systemClass IIa
Hysteroscopic irrigation/insufflation systemHysteroscopic irrigation/insufflation systemClass IIb
Hysteroscopy cervical leakage sheathHysteroscopy cervical leakage sheathClass I
Ice bagIce bagClass I
Iliac artery stent, bare-metalIliac artery stent, bare-metalClass IIb
Iliac artery stent, bare-metalIliac artery stent, bare-metalClass III
Iliofemoral artery endovascular stent-graftIliofemoral artery endovascular stent-graftClass IIb
Iliofemoral artery endovascular stent-graftIliofemoral artery endovascular stent-graftClass III
Iliofemoral vein stentIliofemoral vein stentClass IIa
Iliofemoral vein stentIliofemoral vein stentClass IIb
Image-based pain-assessment softwareImage-based pain-assessment softwareClass I
Image display monitor holderImage display monitor holderClass I
Image display monitor, colourImage display monitor, colour
Image display monitor, colourImage display monitor, colourClass I
Image display monitor, colourImage display monitor, colourClass IIa
Image display monitor, colourImage display monitor, colourClass IIb
Image Reversing DevicesImage Reversing DevicesClass I
Image segmentation application softwareImage segmentation application software
Image segmentation application softwareImage segmentation application softwareClass I