EMDN R90: Respiratory and Anaesthesia Devices - Various

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.

• R90Respiratory and Anaesthesia Devices - Various
  • R9001Respiratory MouthpiecesMDR 2 classes · n=79terminal

    Registered in EUDAMED under MDR with this code, the 79 devices are split across classes (as of 8 Sep 2026).

    • 54 Class I (68.3%)
    • 25 Class IIa (31.6%)

    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.

  • R9002Laryngoscope Blades, Single-UseMDR 99.5% Class I · n=729MDD 100.0% Class I · n=316terminal

    Registered in EUDAMED under MDR with this code: 726 of 729 devices carry Class I on their registration (as of 8 Sep 2026).

    • 726 Class I (99.5%)
    • 3 Class IIa (0.4%)

    Registered in EUDAMED under MDD with this code: 316 of 316 devices carry Class I on their registration (as of 8 Sep 2026).

    • 316 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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • R9003Respiratory System Surgery Instruments, Single-Use
    • R900301Respiratory System Surgery Forceps, Single-Useterminal
    • R900302Respiratory System Surgery Dilators, Single-Useterminal
    • R900399Respiratory System Surgery Instruments, Single-Use - Otherterminal
  • R9004Pleural Talcage Devicesterminal
  • R9005Endobronchial Valves and Release Systemsterminal
  • R9006Phonation Valves
    • R900602Phonation Valves for Tracheostomy
      • R90060201Phonation Valves for Tracheostomy for Ventilator Useterminal
      • R90060202Phonation Valves for Tracheostomy not for Ventilator UseMDR 2 classes · n=34terminal

        Registered in EUDAMED under MDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).

        • 20 Class I (58.8%)
        • 14 Class IIa (41.1%)

        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.

    • R900680Phonation Valves - Accessoriesterminal
  • R9007Lung Functionality Testing Devices, Single-Use - not Included in Other Classesterminal
  • R9008Respiratory System Active Substancesterminal
  • R9009Respiratory Therapy Aids
    • R900901InhalersMDR 2 classes · n=148terminal

      Registered in EUDAMED under MDR with this code, the 148 devices are split across classes (as of 8 Sep 2026).

      • 121 Class IIa (81.7%)
      • 27 Class I (18.2%)

      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.

    • R900902Inspiratory and Expiratory Flow Stimulators/Respiratory Muscles TrainersMDR 95.4% Class I · n=132MDD 3 classes · n=35terminal

      Registered in EUDAMED under MDR with this code: 126 of 132 devices carry Class I on their registration (as of 8 Sep 2026).

      • 126 Class I (95.4%)
      • 6 Class IIa (4.5%)

      Registered in EUDAMED under MDD with this code, the 35 devices are split across classes (as of 8 Sep 2026).

      • 32 Class I (91.4%)
      • 2 Class IIb (5.7%)
      • 1 Class IIa (2.8%)

      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.

  • R9080Respiratory and Anesthesia Devices - Accessories not Included in Other ClassesMDR 3 classes · n=557MDD 3 classes · n=81terminal

    Registered in EUDAMED under MDR with this code, the 557 devices are split across classes (as of 8 Sep 2026).

    • 421 Class I (75.5%)
    • 72 Class IIa (12.9%)
    • 64 Class IIb (11.4%)

    Registered in EUDAMED under MDD with this code, the 81 devices are split across classes (as of 8 Sep 2026).

    • 63 Class IIa (77.7%)
    • 15 Class I (18.5%)
    • 3 Class IIb (3.7%)

    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.

  • R9099Respiratory and Anaesthesia Devices - OtherMDR 3 classes · n=1,346MDD 3 classes · n=366terminal

    Registered in EUDAMED under MDR with this code, the 1,346 devices are split across classes (as of 8 Sep 2026).

    • 729 Class IIa (54.1%)
    • 554 Class I (41.1%)
    • 63 Class IIb (4.6%)

    Registered in EUDAMED under MDD with this code, the 366 devices are split across classes (as of 8 Sep 2026).

    • 219 Class IIb (59.8%)
    • 100 Class IIa (27.3%)
    • 47 Class I (12.8%)

    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.