EMDN R05: Suction and Dilatation Systems for the Respiratory System

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.

• R05Suction and Dilatation Systems for the Respiratory System
  • R0501Respiratory Suction Probes and Systems
    • R050101Respiratory Suction Probes
      • R05010101Respiratory Suction Probes without A Control HoleMDR 2 classes · n=321MDD 100.0% Class IIa · n=134terminal

        Registered in EUDAMED under MDR with this code, the 321 devices are split across classes (as of 8 Sep 2026).

        • 301 Class IIa (93.7%)
        • 20 Class I (6.2%)

        Registered in EUDAMED under MDD with this code: 134 of 134 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 134 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.

      • R05010102Respiratory Suction Probes with Control HoleMDR 99.8% Class IIa · n=599MDD 100.0% Class IIa · n=142terminal

        Registered in EUDAMED under MDR with this code: 598 of 599 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 598 Class IIa (99.8%)
        • 1 Class I (0.1%)

        Registered in EUDAMED under MDD with this code: 142 of 142 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 142 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.

    • R050102Closed-Circuit Respiratory Suction and Irrigation Systems (Non-Endoscopic)MDR 99.2% Class IIa · n=571MDD 100.0% Class IIa · n=259terminal

      Registered in EUDAMED under MDR with this code: 567 of 571 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 567 Class IIa (99.2%)
      • 4 Class I (0.7%)

      Registered in EUDAMED under MDD with this code: 259 of 259 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 259 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.

    • R050103Mucous Aspirators
      • R05010301Single-Chamber Mucous Membrane AspiratorsMDR 2 classes · n=354MDD 97.0% Class IIa · n=34terminal

        Registered in EUDAMED under MDR with this code, the 354 devices are split across classes (as of 8 Sep 2026).

        • 258 Class IIa (72.8%)
        • 96 Class I (27.1%)

        Registered in EUDAMED under MDD with this code: 33 of 34 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 33 Class IIa (97.0%)
        • 1 Class IIb (2.9%)

        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.

      • R05010302Double-Chamber Mucous Membrane Aspiratorsterminal
      • R05010399Mucosity Aspirators - OtherMDR 2 classes · n=545terminal

        Registered in EUDAMED under MDR with this code, the 545 devices are split across classes (as of 8 Sep 2026).

        • 460 Class IIa (84.4%)
        • 85 Class I (15.5%)

        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.

  • R0502Respiratory Dilation Systems
    • R050201Bronchial Dilation CathetersMDR 100.0% Class I · n=609terminal

      Registered in EUDAMED under MDR with this code: 609 of 609 devices carry Class I on their registration (as of 8 Sep 2026).

      • 609 Class I (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.

    • R050280Respiratory Tract Expansion Systems - Accessoriesterminal
    • R050299Respiratory Dilation Systems - Otherterminal
  • R0580Respiratory System Suction and Dilatation Systems - Accessories not Included in Other ClassesMDR 2 classes · n=48terminal

    Registered in EUDAMED under MDR with this code, the 48 devices are split across classes (as of 8 Sep 2026).

    • 45 Class I (93.7%)
    • 3 Class IIa (6.2%)

    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.

  • R0599Respiratory Devices, Suction and Dilation Systems - OtherMDR 2 classes · n=476MDD 100.0% Class IIa · n=44terminal

    Registered in EUDAMED under MDR with this code, the 476 devices are split across classes (as of 8 Sep 2026).

    • 430 Class IIa (90.3%)
    • 46 Class I (9.6%)

    Registered in EUDAMED under MDD with this code: 44 of 44 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 44 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.