EMDN C03: Cardiac Surgery and Heart Transplant Devices

Registered classes, as of 8 Sep 2026. For each code with at least 20 registrations under a legislation, the chip shows how devices registered in EUDAMED under that code are classed, counted once per primary UDI-DI and kept separate for each legislation. It is not a determination. The class of a device comes from the MDR and IVDR classification rules for its intended purpose. MDD and IVDD classes are the directive classification and can differ from the class the same device would have under MDR or IVDR.

• C03Cardiac Surgery and Heart Transplant Devices
  • C0301Extracorporeal Assisted Circulation Devices
    • C030101Extracorporeal Circulation Kits
      • C03010101Extracorporeal Circulation CircuitsMDR 3 classes · n=151MDD 99.7% Class IIa · n=1,696terminal

        Registered in EUDAMED under MDR with this code, the 151 devices are split across classes (as of 8 Sep 2026).

        • 104 Class IIa (68.8%)
        • 36 Class IIb (23.8%)
        • 11 Class III (7.2%)

        Registered in EUDAMED under MDD with this code: 1,691 of 1,696 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 1,691 Class IIa (99.7%)
        • 5 Class IIb (0.2%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • C03010102Oxygenator KitsMDR 99.3% Class IIa · n=159MDD 100.0% Class IIa · n=49terminal

        Registered in EUDAMED under MDR with this code: 158 of 159 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 158 Class IIa (99.3%)
        • 1 Class IIb (0.6%)

        Registered in EUDAMED under MDD with this code: 49 of 49 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 49 Class IIa (100.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • C03010104Extracorporeal Circulation FiltersMDR 3 classes · n=99terminal

        Registered in EUDAMED under MDR with this code, the 99 devices are split across classes (as of 8 Sep 2026).

        • 89 Class IIb (89.8%)
        • 9 Class IIa (9.0%)
        • 1 Class I (1.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

      • C03010199Extracorporeal Circulation Kits - OtherMDR 2 classes · n=99MDD 100.0% Class IIa · n=39terminal

        Registered in EUDAMED under MDR with this code, the 99 devices are split across classes (as of 8 Sep 2026).

        • 92 Class IIa (92.9%)
        • 7 Class I (7.0%)

        Registered in EUDAMED under MDD with this code: 39 of 39 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 39 Class IIa (100.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • C030102Cardioplegia Solution Administration KitsMDD 100.0% Class IIa · n=61terminal

      Registered in EUDAMED under MDD with this code: 61 of 61 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 61 Class IIa (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • C030103Circulatory Support Kits
      • C03010301Cardiopulmonary Support Kits (C.p.s. and Ecmo)MDR 96.8% Class IIa · n=188terminal

        Registered in EUDAMED under MDR with this code: 182 of 188 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 182 Class IIa (96.8%)
        • 4 Class III (2.1%)
        • 2 Class I (1.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

      • C03010399Circulatory Support Kits - Otherterminal
    • C030104Extracorporeal Circulation Cannulas
      • C03010401Extracorporeal Circulation Arterial Cannulas
        • C0301040101Extracorporeal Circulation Arterial Cannulas, W/O FilterMDD 98.0% Class III · n=50terminal

          Registered in EUDAMED under MDD with this code: 49 of 50 devices carry Class III on their registration (as of 8 Sep 2026).

          • 49 Class III (98.0%)
          • 1 Class IIa (2.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • C0301040102Extracorporeal Circulation Arterial Cannulas, with Filterterminal
      • C03010402Extracorporeal Circulation Venous Cannulas
        • C0301040201Atriocaval CannulasMDD 100.0% Class III · n=80terminal

          Registered in EUDAMED under MDD with this code: 80 of 80 devices carry Class III on their registration (as of 8 Sep 2026).

          • 80 Class III (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • C0301040202Bicaval Cannulasterminal
      • C03010403Intracavitary Suction CannulasMDD 2 classes · n=20terminal

        Registered in EUDAMED under MDD with this code, the 20 devices are split across classes (as of 8 Sep 2026).

        • 13 Class III (65.0%)
        • 7 Class IIa (35.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • C03010404Cardioplegia Cannulas
        • C0301040401Extracorporeal Circulation Non-Selective Perfusion Cannulas (with Aortic Venting Lumen)terminal
        • C0301040402Selective Coronary Arteries Perfusion Cannulasterminal
        • C0301040499Cardioplegia Cannulas - Otherterminal
      • C03010405Selective Carotid Artery and Coronary Sinus Perfusion Cannulasterminal
      • C03010406Percutaneous Arteriovenous Cannulas (with Endoclamp and Cardioplegia Venting Lumen)terminal
      • C03010499Extracorporeal Circulation Cannulas - OtherMDR 2 classes · n=42MDD 3 classes · n=75terminal

        Registered in EUDAMED under MDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).

        • 32 Class III (76.1%)
        • 10 Class IIa (23.8%)

        Registered in EUDAMED under MDD with this code, the 75 devices are split across classes (as of 8 Sep 2026).

        • 49 Class III (65.3%)
        • 19 Class IIa (25.3%)
        • 7 Class IIb (9.3%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • C030180Extracorporeal and Assisted Circulation Devices - AccessoriesMDR 3 classes · n=316MDD 2 classes · n=20terminal

      Registered in EUDAMED under MDR with this code, the 316 devices are split across classes (as of 8 Sep 2026).

      • 257 Class IIa (81.3%)
      • 57 Class I (18.0%)
      • 2 Class IIb (0.6%)

      Registered in EUDAMED under MDD with this code, the 20 devices are split across classes (as of 8 Sep 2026).

      • 17 Class I (85.0%)
      • 3 Class IIa (15.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • C030199Extracorporeal and Assisted Circulation Devices - OtherMDR 3 classes · n=52MDD 3 classes · n=33terminal

      Registered in EUDAMED under MDR with this code, the 52 devices are split across classes (as of 8 Sep 2026).

      • 21 Class IIa (40.3%)
      • 18 Class IIb (34.6%)
      • 13 Class I (25.0%)

      Registered in EUDAMED under MDD with this code, the 33 devices are split across classes (as of 8 Sep 2026).

      • 30 Class IIb (90.9%)
      • 2 Class IIa (6.0%)
      • 1 Class III (3.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • C0380Heart Surgery and Organ Transplantation Devices - Accessories not Included in Other Classesterminal
  • C0390Cardiac Surgery and Heart Transplant Devices - Various
    • C039001Minimally Invasive Access Cardiac Surgery Systems
      • C03900101Direct Vision Minimally Invasive Cardiac Access Kitsterminal
      • C03900102Mini-Invasive Video-Assisted Cardio-Surgical Access Kits (with External Monitor)terminal
    • C039002Beating Heart Cardiosurgery Devices
      • C03900201Epi-Myocardial Stabilisation Kitsterminal
      • C03900202Intracoronary Shuntsterminal
      • C03900203Gas-Jet Cardiac Surgery Field Cleansing Kits (Blower)terminal
      • C03900299Beating Heart Cardiosurgery Devices - OtherMDD 100.0% Class IIa · n=33terminal

        Registered in EUDAMED under MDD with this code: 33 of 33 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 33 Class IIa (100.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • C0399Cardiosurgery and Organ Transplantation Devices - OtherMDR 3 classes · n=27MDD 2 classes · n=23terminal

    Registered in EUDAMED under MDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).

    • 20 Class IIa (74.0%)
    • 4 Class IIb (14.8%)
    • 3 Class III (11.1%)

    Registered in EUDAMED under MDD with this code, the 23 devices are split across classes (as of 8 Sep 2026).

    • 16 Class III (69.5%)
    • 7 Class IIa (30.4%)

    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.