Devices

Generic Code / Group Code Product Name Generic Name or Short Description Nomenclature Type
10% Formaldehyde solution IVD10% Formaldehyde solution IVDClass A
10% Formaldehyde solution IVD10% Formaldehyde solution IVDIVD General
10% Neutral buffered formalin IVD10% Neutral buffered formalin IVDClass A
10% Neutral buffered formalin (zinc) IVD10% Neutral buffered formalin (zinc) IVDClass A
125-Dihydroxy vitamin D3 IVD calibrator125-Dihydroxy vitamin D3 IVD calibratorIVD General
125-Dihydroxy vitamin D3 IVD control125-Dihydroxy vitamin D3 IVD controlIVD General
125-Dihydroxy vitamin D3 IVD kit chemiluminescent immunoassay125-Dihydroxy vitamin D3 IVD kit chemiluminescent immunoassayIVD General
125-Dihydroxy vitamin D3 IVD kit radioimmunoassay125-Dihydroxy vitamin D3 IVD kit radioimmunoassayIVD General
125-Dihydroxy vitamin D3 IVD reagent125-Dihydroxy vitamin D3 IVD reagentClass A
125-Dihydroxy vitamin D3 IVD reagent125-Dihydroxy vitamin D3 IVD reagentIVD Devices for Self-Testing
125-Dihydroxy vitamin D3 IVD reagent125-Dihydroxy vitamin D3 IVD reagentIVD General
13-Beta-D-glucan IVD control13-Beta-D-glucan IVD controlClass C
13-Beta-D-glucan IVD control13-Beta-D-glucan IVD controlIVD General
13-Beta-D-glucan IVD kit enzyme immunoassay (EIA)13-Beta-D-glucan IVD kit enzyme immunoassay (EIA)IVD General
13-Beta-D-glucan IVD kit enzyme spectrophotometry13-Beta-D-glucan IVD kit enzyme spectrophotometryIVD General
13-Beta-D-glucan IVD kit nephelometry/turbidimetry13-Beta-D-glucan IVD kit nephelometry/turbidimetryClass C
13-Beta-D-glucan IVD kit nephelometry/turbidimetry13-Beta-D-glucan IVD kit nephelometry/turbidimetryIVD General
13-Beta-D-glucan IVD reagent13-Beta-D-glucan IVD reagentClass A
13-Beta-D-glucan IVD reagent13-Beta-D-glucan IVD reagentIVD General
17-Hydroxyprogesterone IVD control17-Hydroxyprogesterone IVD controlIVD General
17-Hydroxyprogesterone IVD kit chemiluminescent immunoassay17-Hydroxyprogesterone IVD kit chemiluminescent immunoassayIVD General
17-Hydroxyprogesterone IVD kit enzyme immunoassay (EIA)17-Hydroxyprogesterone IVD kit enzyme immunoassay (EIA)IVD General
17-Hydroxyprogesterone IVD kit fluorescent immunoassay17-Hydroxyprogesterone IVD kit fluorescent immunoassayIVD General
17-Hydroxyprogesterone IVD kit radioimmunoassay17-Hydroxyprogesterone IVD kit radioimmunoassayClass B
17-Hydroxyprogesterone IVD kit radioimmunoassay17-Hydroxyprogesterone IVD kit radioimmunoassayIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibrator2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibratorIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD control2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD controlIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)IVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD reagent2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD reagentIVD General
24-hour urine specimen container IVD no additive24-hour urine specimen container IVD no additiveIVD General
25-Hydroxy vitamin D2 IVD control25-Hydroxy vitamin D2 IVD controlIVD General
25-Hydroxy vitamin D2 IVD kit liquid chromatography25-Hydroxy vitamin D2 IVD kit liquid chromatographyIVD General
25-Hydroxy vitamin D2 IVD reagent25-Hydroxy vitamin D2 IVD reagentIVD General
25-Hydroxy vitamin D3 IVD calibrator25-Hydroxy vitamin D3 IVD calibratorIVD General
25-Hydroxy vitamin D3 IVD control25-Hydroxy vitamin D3 IVD controlIVD General
25-Hydroxy vitamin D3 IVD kit liquid chromatography25-Hydroxy vitamin D3 IVD kit liquid chromatographyIVD General
25-Hydroxy vitamin D3 IVD kit radioimmunoassay25-Hydroxy vitamin D3 IVD kit radioimmunoassayIVD General
25-Hydroxy vitamin D3 IVD reagent25-Hydroxy vitamin D3 IVD reagentIVD General
3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD kit chemiluminescent immunoassay3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD kit chemiluminescent immunoassayIVD General
37% Formaldehyde solution IVD37% Formaldehyde solution IVDClass A
37% Formaldehyde solution IVD37% Formaldehyde solution IVDIVD General
5-Fluorocytosine susceptibility testing disc IVD5-Fluorocytosine susceptibility testing disc IVDIVD General
5-Fluorouracil (5-FU) therapeutic drug monitoring IVD calibrator5-Fluorouracil (5-FU) therapeutic drug monitoring IVD calibratorIVD General
5-Fluorouracil (5-FU) therapeutic drug monitoring IVD control5-Fluorouracil (5-FU) therapeutic drug monitoring IVD controlIVD General
5-Fluorouracil (5-FU) therapeutic drug monitoring IVD reagent5-Fluorouracil (5-FU) therapeutic drug monitoring IVD reagentIVD General
5-Hydroxyindoleacetic acid (5HIAA) IVD reagent5-Hydroxyindoleacetic acid (5HIAA) IVD reagentIVD General
6-Acetyl morphine IVD calibrator6-Acetyl morphine IVD calibratorIVD General
6-Acetyl morphine IVD control6-Acetyl morphine IVD controlIVD General
6-Acetyl morphine IVD kit enzyme immunoassay (EIA)6-Acetyl morphine IVD kit enzyme immunoassay (EIA)IVD General
6-Acetyl morphine IVD kit rapid ICT clinical6-Acetyl morphine IVD kit rapid ICT clinicalIVD General
6-Acetyl morphine IVD reagent6-Acetyl morphine IVD reagentIVD General
Abdominal aorta endovascular stent-graftAbdominal aorta endovascular stent-graft Conformity Assessment Certificate ExpiredClass III
Abdominal aorta endovascular stent-graftAbdominal aorta endovascular stent-graft
Abdominal aorta endovascular stent-graftAbdominal aorta endovascular stent-graftClass IIb
Abdominal aorta endovascular stent-graftAbdominal aorta endovascular stent-graftClass III
Abdominal binder reusableAbdominal binder reusable
Abdominal binder reusableAbdominal binder reusableClass I
Abdominal binder single-useAbdominal binder single-useClass I
Abdominal fistula drainage catheter portAbdominal fistula drainage catheter port Conformity Assessment Certificate ExpiredClass IIb
Abdominal hernia surgical mesh synthetic polymer bioabsorbableAbdominal hernia surgical mesh synthetic polymer bioabsorbableClass III
Abdominal hernia truss reusableAbdominal hernia truss reusableClass I
Abdominal hernia truss single-useAbdominal hernia truss single-use
Abdominal hernia truss single-useAbdominal hernia truss single-useClass I
Abdominal hernia truss single-useAbdominal hernia truss single-useClass IIb
Abdominal paracentesis needle single-useAbdominal paracentesis needle single-use Conformity Assessment Certificate ExpiredClass IIa
Abdominal paracentesis needle single-useAbdominal paracentesis needle single-useClass IIa
Abdominal scissorsAbdominal scissorsClass I
Abdominal/ENT/orthopaedic surgical probe reusableAbdominal/ENT/orthopaedic surgical probe reusableClass I
Abdominal/ENT/orthopaedic surgical probe reusableAbdominal/ENT/orthopaedic surgical probe reusableClass IIa
Abdominal/ENT/orthopaedic surgical probe single-useAbdominal/ENT/orthopaedic surgical probe single-useClass I
Abdominal/ENT/orthopaedic surgical probe single-useAbdominal/ENT/orthopaedic surgical probe single-useClass IIa
Abdominal/intestinal spatulaAbdominal/intestinal spatulaClass I
ABO grouping cellsABO grouping cellsIVD Annex II List A
ABO multiple blood grouping IVD kit agglutinationABO multiple blood grouping IVD kit agglutinationIVD Annex II List A
ABO multiple blood grouping IVD kit agglutinationABO multiple blood grouping IVD kit agglutinationIVD General
Abortion suction system manual aspiratorAbortion suction system manual aspiratorClass I
Abortion suction system manual aspiratorAbortion suction system manual aspiratorClass IIa
ABO/Rh multiple blood grouping IVD kit agglutinationABO/Rh multiple blood grouping IVD kit agglutinationIVD Annex II List A
ABO/Rh multiple blood grouping IVD kit agglutinationABO/Rh multiple blood grouping IVD kit agglutinationIVD General
ABO/Rh(D) blood grouping analyser IVD semi-automatedABO/Rh(D) blood grouping analyser IVD semi-automatedIVD General
ABO/Rh(D)/IgG multiple blood grouping IVD kit agglutinationABO/Rh(D)/IgG multiple blood grouping IVD kit agglutinationIVD Annex II List A
ABO/Rh(D)/IgG multiple blood grouping IVD kit agglutinationABO/Rh(D)/IgG multiple blood grouping IVD kit agglutinationIVD Annex II List B
ABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationClass C
ABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationIVD Annex II List A
ABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationIVD Annex II List B
ABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationIVD General
Absorbent stomal dressingAbsorbent stomal dressingClass I
Absorbent tipped applicator non-sterileAbsorbent tipped applicator non-sterileClass I
Absorbent underpad antimicrobialAbsorbent underpad antimicrobialClass IIa
Absorbent underpad non-antimicrobial reusableAbsorbent underpad non-antimicrobial reusableClass I
Absorbent underpad non-antimicrobial single-useAbsorbent underpad non-antimicrobial single-useClass I
Absorbent wound compression padAbsorbent wound compression pad
Absorbent wound compression padAbsorbent wound compression padClass I
Accelerator system collimator electron applicatorAccelerator system collimator electron applicatorClass I
Accelerator system quality assurance deviceAccelerator system quality assurance deviceClass I
Accelerator system quality assurance deviceAccelerator system quality assurance deviceClass IIb
Accelerator system synchronizerAccelerator system synchronizerClass IIb
Accelerator system table non-poweredAccelerator system table non-poweredClass I
Accelerator system table poweredAccelerator system table poweredClass I
Accelerator system table poweredAccelerator system table poweredClass IIb
Accessories For Implantable Devices (Non-Invasive)Accessories For Implantable Devices (Non-Invasive)Class I
Acetabular augmentation implantAcetabular augmentation implant
Acetabular augmentation implantAcetabular augmentation implantClass IIb
Acetabular augmentation implantAcetabular augmentation implantClass III
Acetabular liner locking ringAcetabular liner locking ring Conformity Assessment Certificate ExpiredClass III
Acetabular orthopaedic reamerAcetabular orthopaedic reamer Conformity Assessment Certificate ExpiredClass IIa
Acetabular orthopaedic reamerAcetabular orthopaedic reamerClass I
Acetabular orthopaedic reamerAcetabular orthopaedic reamerClass IIa
Acetabular orthopaedic reamerAcetabular orthopaedic reamerClass III
Acetabular shellAcetabular shell Conformity Assessment Certificate ExpiredClass III
Acetabular shellAcetabular shell
Acetabular shellAcetabular shellClass IIb
Acetabular shellAcetabular shellClass III
Acetabulum prosthesis hole plugAcetabulum prosthesis hole plug Conformity Assessment Certificate ExpiredClass III
Acetabulum prosthesis hole plugAcetabulum prosthesis hole plug
Acetabulum prosthesis hole plugAcetabulum prosthesis hole plugClass IIb
Acetabulum prosthesis hole plugAcetabulum prosthesis hole plugClass III
Acetabulum prosthesis trial custom-madeAcetabulum prosthesis trial custom-made
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusable
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusableClass I
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusableClass IIa
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusableClass III
Acetabulum prosthesis trial prefabricated single-useAcetabulum prosthesis trial prefabricated single-use
Acetaminophen IVD calibratorAcetaminophen IVD calibratorIVD General
Acetaminophen IVD controlAcetaminophen IVD controlIVD General
Acetaminophen IVD kit enzyme immunoassay (EIA)Acetaminophen IVD kit enzyme immunoassay (EIA)IVD General
Acetaminophen IVD kit enzyme spectrophotometryAcetaminophen IVD kit enzyme spectrophotometryIVD General
Acetaminophen IVD kit rapid ICT clinicalAcetaminophen IVD kit rapid ICT clinicalIVD General
Acetaminophen IVD reagentAcetaminophen IVD reagentIVD General
Acetone IVD reagentAcetone IVD reagentIVD General
Acetone solution IVDAcetone solution IVDClass A
Acetylcholine receptor antibody IVD kit enzyme immunoassay (EIA)Acetylcholine receptor antibody IVD kit enzyme immunoassay (EIA)IVD General
Acetylcholine receptor antibody IVD kit radioimmunoassayAcetylcholine receptor antibody IVD kit radioimmunoassayIVD General
Acetylcholinesterase IVD kit enzyme spectrophotometryAcetylcholinesterase IVD kit enzyme spectrophotometryIVD General
Acetylcholinesterase IVD reagentAcetylcholinesterase IVD reagentIVD General
Acid-alcohol solution IVDAcid-alcohol solution IVDClass A
Acid-alcohol solution IVDAcid-alcohol solution IVDIVD General
Acid phosphatase isoenzyme IVD controlAcid phosphatase isoenzyme IVD controlIVD General
Acid phosphatase isoenzyme IVD reagentAcid phosphatase isoenzyme IVD reagentIVD General
Acoustic earmuffsAcoustic earmuffs
Acoustic rhinometerAcoustic rhinometerClass IIa
Acromioclavicular joint stabilization implantAcromioclavicular joint stabilization implantClass IIb
Activated-medium surgical warming blanketActivated-medium surgical warming blanketClass I
Activated-medium surgical warming blanketActivated-medium surgical warming blanketClass IIa
Activated-medium surgical warming blanketActivated-medium surgical warming blanketClass IIb
Activated-oxygen generatorActivated-oxygen generatorClass I
Activated clotting time (ACT) IVD controlActivated clotting time (ACT) IVD controlIVD General
Activated clotting time (ACT) IVD kit clottingActivated clotting time (ACT) IVD kit clottingIVD General
Activated clotting time (ACT) IVD reagentActivated clotting time (ACT) IVD reagentIVD General
Activated partial thromboplastin time (APTT) IVD controlActivated partial thromboplastin time (APTT) IVD controlIVD General
Activated partial thromboplastin time (APTT) IVD kit clottingActivated partial thromboplastin time (APTT) IVD kit clottingClass C
Activated partial thromboplastin time (APTT) IVD kit clottingActivated partial thromboplastin time (APTT) IVD kit clottingIVD General
Activated partial thromboplastin time (APTT) IVD kit rapid clotting clinicalActivated partial thromboplastin time (APTT) IVD kit rapid clotting clinicalIVD General
Activated partial thromboplastin time (APTT) IVD reagentActivated partial thromboplastin time (APTT) IVD reagentIVD General
Activated protein C resistance ratio (APCR) IVD controlActivated protein C resistance ratio (APCR) IVD controlIVD General
Activated protein C resistance ratio (APCR) IVD kit clottingActivated protein C resistance ratio (APCR) IVD kit clottingIVD General
Activated protein C resistant factor V (factor V Leiden) IVD controlActivated protein C resistant factor V (factor V Leiden) IVD controlIVD General
Activated protein C resistant factor V (factor V Leiden) IVD kit clottingActivated protein C resistant factor V (factor V Leiden) IVD kit clottingIVD General
Active implantable device control magnetActive implantable device control magnet
Active implantable device control magnetActive implantable device control magnetClass III
Active Medical Device Accessories (e.g. batteries chargers power supply units)Active Medical Device Accessories (e.g. batteries chargers power supply units)Class I
Acupressure applicator reusableAcupressure applicator reusableClass I
Acupressure calf bandAcupressure calf bandClass I
Acupressure Devices and Copper BraceletsAcupressure Devices and Copper BraceletsClass I
Acupressure wristbandAcupressure wristbandClass I
Acupuncture electrical stimulation systemAcupuncture electrical stimulation systemClass IIa
Acupuncture electrical stimulation systemAcupuncture electrical stimulation systemClass IIb
Acupuncture needle single-useAcupuncture needle single-use Conformity Assessment Certificate ExpiredClass IIa
Acupuncture needle single-useAcupuncture needle single-useClass IIa
Acupuncture point detectorAcupuncture point detectorClass IIa
Acute myeloid leukaemia (AML) genetic mutation IVD kit nucleic acid technique (NAT)Acute myeloid leukaemia (AML) genetic mutation IVD kit nucleic acid technique (NAT)IVD General
Acute myeloid leukaemia (AML) genetic mutation IVD probeAcute myeloid leukaemia (AML) genetic mutation IVD probeIVD General
Acute promyelocytic leukaemia (APL) genetic mutation IVD kit nucleic acid technique (NAT)Acute promyelocytic leukaemia (APL) genetic mutation IVD kit nucleic acid technique (NAT)IVD General
Acute promyelocytic leukaemia (APL) genetic mutation IVD probeAcute promyelocytic leukaemia (APL) genetic mutation IVD probeIVD General
ADAMTS13 activity IVD kit chemiluminescent immunoassayADAMTS13 activity IVD kit chemiluminescent immunoassayIVD General
AdaptometerAdaptometerClass I
Adeno-associated virus neutralizing antibody IVD kit bioassayAdeno-associated virus neutralizing antibody IVD kit bioassayIVD General
Adenoid curette reusableAdenoid curette reusableClass I
Adenoid curette single-useAdenoid curette single-useClass IIa
Adenosine deaminase (ADA) IVD calibratorAdenosine deaminase (ADA) IVD calibratorIVD General
Adenosine deaminase (ADA) IVD controlAdenosine deaminase (ADA) IVD controlIVD General
Adenosine deaminase (ADA) IVD kit spectrophotometryAdenosine deaminase (ADA) IVD kit spectrophotometryIVD General
Adenosine deaminase (ADA) IVD reagentAdenosine deaminase (ADA) IVD reagentIVD General
Adenotome blade reusableAdenotome blade reusableClass I
AdenotomeAdenotomeClass I
Adenovirus antigen IVD antibodyAdenovirus antigen IVD antibodyIVD General
Adenovirus antigen IVD controlAdenovirus antigen IVD controlIVD General
Adenovirus antigen IVD kit chemiluminescent immunoassayAdenovirus antigen IVD kit chemiluminescent immunoassayIVD General
Adenovirus antigen IVD kit enzyme immunoassay (EIA)Adenovirus antigen IVD kit enzyme immunoassay (EIA)IVD General
Adenovirus antigen IVD kit fluorescent immunoassayAdenovirus antigen IVD kit fluorescent immunoassayIVD General
Adenovirus antigen IVD kit rapid ICT clinicalAdenovirus antigen IVD kit rapid ICT clinicalIVD General
Adenovirus antigen IVD reagentAdenovirus antigen IVD reagentIVD General
Adenovirus immunoglobulin A (IgA) antibody IVD controlAdenovirus immunoglobulin A (IgA) antibody IVD controlIVD General
Adenovirus immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA)Adenovirus immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA)IVD General
Adenovirus immunoglobulin A (IgA) antibody IVD kit fluorescent immunoassayAdenovirus immunoglobulin A (IgA) antibody IVD kit fluorescent immunoassayIVD General
Adenovirus immunoglobulin G (IgG) antibody IVD controlAdenovirus immunoglobulin G (IgG) antibody IVD controlIVD General
Adenovirus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Adenovirus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Adenovirus immunoglobulin G (IgG) antibody IVD reagentAdenovirus immunoglobulin G (IgG) antibody IVD reagentIVD General
Adenovirus immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)Adenovirus immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)IVD General
Adenovirus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Adenovirus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General