EMDN J01: Cardiac Functionality Implantable Devices

Complete hierarchy for EMDN group J01 in category J (Active-Implantable Devices): 55 terminal codes, EMDN v2026. Terminal codes are the ones accepted in a EUDAMED device record.

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.

  • J01Cardiac Functionality Implantable Devices
    • J0101Implantable Pacemakers
      • J010101Implantable Single Chamber Pacemakers
        • J01010101Implantable Single Chamber Pacemakers (Sc)terminal
        • J01010102Implantable Single Chamber Pacemakers with Sensor (Sr)terminal
      • J010102Implantable Single Lead Pacemakers
        • J01010201Implantable Single Lead VDD Pacemakersterminal
        • J01010202Implantable Single Lead VDDR Pacemakers with Sensorterminal
      • J010103Implantable Dual Chamber Pacemakers
        • J01010301Implantable Dual Chamber Pacemakers (Dc)terminal
        • J01010302Implantable Dual Chamber Pacemakers with Sensor (Dr)terminal
      • J010104Implantable Triple Chamber Pacemakers
        • J01010401Implantable Triple Chamber Pacemakers for Cardiac Resynchronization (Tr)terminal
      • J010105Implantable Pacemakers with Incorporated Electrodes (Leadless)terminal
      • J010180Implantable Pacemakers - Accessoriesterminal
      • J010199Implantable Pacemakers - Otherterminal
    • J0102Implantable Cardiac Diagnostic Devices
      • J010201Implantable Diagnostic Arrhythmias Recording Cardiac Devicesterminal
      • J010280Implantable Cardiac Diagnostic Devices - Accessoriesterminal
      • J010299Implantable Cardiac Diagnostic Devices - Otherterminal
    • J0103Implantable Ventricular Assistance Systems
      • J010301Implantable Monoventricular and Biventricular Assistance Systems
        • J01030101Implantable Right Monoventricular Assistance Systems (Rvad)terminal
        • J01030102Implantable Left Monoventricular Assistance Systems (Lvad)MDR 100.0% Class III · n=35terminal

          Registered in EUDAMED under MDR with this code: 35 of 35 devices carry Class III on their registration (as of 8 Sep 2026).

          • 35 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.

        • J01030103Implantable Biventricular Assistance Systems (Bivad)terminal
      • J010380Implantable Ventricular Assistance Systems - Accessoriesterminal
      • J010399Implantable Ventricular Assistance Systems - Otherterminal
    • J0104Implantable Artificial Heart and Implant Kits
      • J010401Implantable Artificial Heart and Implant Kitsterminal
      • J010480Implantable Artificial Heart and Implant Kits - Accessoriesterminal
      • J010499Implantable Artificial Heart and Implant Kits - Otherterminal
    • J0105Implantable Defibrillators
      • J010501Implantable Single Chamber Defibrillators
        • J01050101Implantable Single Chamber Defibrillators, with SensorsMDR 100.0% Class III · n=42terminal

          Registered in EUDAMED under MDR with this code: 42 of 42 devices carry Class III on their registration (as of 8 Sep 2026).

          • 42 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.

      • J010502Implantable Dual Chamber Defibrillators
        • J01050201Implantable Dual Chamber Defibrillators, with SensorsMDR 100.0% Class III · n=42terminal

          Registered in EUDAMED under MDR with this code: 42 of 42 devices carry Class III on their registration (as of 8 Sep 2026).

          • 42 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.

      • J010503Implantable Triple Chamber Defibrillators
        • J01050301Implantable Triple Chamber Defibrillators, with SensorsMDR 100.0% Class III · n=74terminal

          Registered in EUDAMED under MDR with this code: 74 of 74 devices carry Class III on their registration (as of 8 Sep 2026).

          • 74 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.

      • J010504Subcutaneous Implantable Defibrillatorsterminal
      • J010580Implantable Defibrillators - Accessoriesterminal
      • J010599Implantable Defibrillators - Otherterminal
    • J0106Cardiac Contractility Modulation Implantable Devicesterminal
    • J0107Active Implantable Cardiac Devices Remote Monitoring Systems
      • J010701Pulmonary Blood Pressure Remote Monitoring Systems (Including Sensors)terminal
      • J010702Pacemaker and Implantable Defibrillator Remote Monitoring SystemsMDR 100.0% Class III · n=22terminal

        Registered in EUDAMED under MDR with this code: 22 of 22 devices carry Class III on their registration (as of 8 Sep 2026).

        • 22 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.

      • J010780Active Implantable Cardiac Devices Remote Monitoring Systems - Hardware Accessoriesterminal
      • J010782Active Implantable Cardiac Devices Remote Monitoring Systems - Software Accessoriesterminal
      • J010792Active Implantable Cardiac Devices Remote Monitoring Systems - Medical Device Softwareterminal
      • J010799Active Implantable Cardiac Devices Remote Monitoring Systems - Otherterminal
    • J0190Implantable Cardiac Devices - Various
      • J019001Permanent Cardiac Leads
        • J01900101Permanent Pacemaker Leads (with or W/O Steroid-Elution)
          • J0190010101Endocardial Atrial and Ventricular Leads, Unipolar
            • J019001010101Atrial Leads, Passive Fixationterminal
            • J019001010102Ventricular Leads, Passive Fixationterminal
          • J0190010102Endocardial Atrial and Ventricular Leads, Bipolar (with Active or Passive Fixation)terminal
          • J0190010103Left Ventricular Leads with Coronary Sinus Cannulation System (Triple Chamber P.m.)terminal
          • J0190010104Endocardial Pacemaker Leads, Single-Leadterminal
          • J0190010105Epicardial Permanent Cardiac Leadsterminal
        • J01900102Permanent Defibrillator Leads (Steroid Release Included)
          • J0190010201Permanent Pacing and Defibrillation Right Ventricular Leads (with Active and Passive Fixation)
            • J019001020101Permanent Cardiac Defibrillator Leads, Single Coilterminal
            • J019001020102Permanent Cardiac Defibrillator Leads, Double Coilterminal
            • J019001020199Permanent Pacing and Defibrillation Right Ventricular Leads - Otherterminal
          • J0190010202Permanent Subcutaneous Defibrillator Leadsterminal
        • J01900180Permanent Cardiac Leads - Accessoriesterminal
        • J01900199Permanent Cardiac Leads - Otherterminal
      • J019002Implantable Cardiac Devices Programmers and Accessories
        • J01900203Implantable Cardiac Devices Programmersterminal
        • J01900280Implantable Cardiac Devices Programmers - Hardware Accessoryterminal
        • J01900282Implantable Cardiac Devices Programmers - Software Accessoryterminal
        • J01900285Implantable Cardiac Devices Programmers - Consumablesterminal
        • J01900292Implantable Cardiac Devices Programmers - Medical Device Softwareterminal
      • J019003Active-Implantable Cardiac Systems Magnetised Devicesterminal
      • J019004Active-Implantable Cardiac Systems Adaptorsterminal
      • J019005Cardiac Leads Extraction Systemsterminal
      • J019099Implantable Cardiac Devices - Otherterminal

How J01 is structured

55
terminal codes, selectable in a device record
21
branch headings, not selectable
38
name a specific device type
31%
fallback entries: Other and Accessories

The Cardiac Functionality Implantable Devices branch runs 5 levels deep. 21 entries below are branch headings that group other codes rather than naming a device, so a classification has to resolve all the way down to one of the 55 codes marked terminal.

9 terminal codes are “- Other” entries and 8 are “- Accessories” entries, 31% of the branch. An “- Other” code is the residual slot for devices its siblings do not name, so it is worth ruling out every specific sibling before settling on one.

The largest sub-branch is J0190 (Implantable Cardiac Devices - Various), holding 21 of the 55 terminal codes.

Frequently asked questions

Which J01 codes can be used in a EUDAMED device record?
55 of the 76 codes listed under J01 (Cardiac Functionality Implantable Devices) are terminal and can be selected. The other 21 are branch headings that cannot.
How deep is the J01 hierarchy?
The J01 branch runs 5 levels below the group code. Its largest sub-branch is J0190 (Implantable Cardiac Devices - Various), which holds 21 of the 55 terminal codes.
How many J01 codes are catch-all entries?
9 terminal codes under J01 are "- Other" entries and 8 are "- Accessories" entries, 31% of the branch. The remaining 38 name a specific device type.

Not sure which level to stop at, or which of two plausible codes to submit? The guide to choosing an EMDN code walks the decision level by level, with a worked example and the mistakes that get a EUDAMED registration rejected.

Classifying more than a handful of devices?

EUDAMate maps your device list against all 6,773 terminal EMDN codes with confidence-scored suggestions you review and confirm. Start with a free Readiness Check on your own data.

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Other groups in category J

Source: European Commission, EMDN v2026 official release. Terminal codes are the only codes accepted in a EUDAMED device record. EMDN is a nomenclature, not a risk classification. MDR/IVDR class is determined separately.