EMDN R06: Nebulisation and Humidification Systems

Complete hierarchy for EMDN group R06 in category R (Respiratory and Anaesthesia Devices): 9 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.

  • R06Nebulisation and Humidification Systems
    • R0601Nebulisation Systems
      • R060101Cold Nebulisation SystemsMDR 3 classes · n=788MDD 95.0% Class IIa · n=222terminal

        Registered in EUDAMED under MDR with this code, the 788 devices are split across classes (as of 8 Sep 2026).

        • 694 Class IIa (88.0%)
        • 53 Class I (6.7%)
        • 41 Class IIb (5.2%)

        Registered in EUDAMED under MDD with this code: 211 of 222 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 211 Class IIa (95.0%)
        • 11 Class IIb (4.9%)

        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.

      • R060102Hot Nebulisation Systemsterminal
    • R0602Humidification Systems
      • R060201Active Ventilation Humidification Systems,MDR 2 classes · n=58MDD 2 classes · n=104terminal

        Registered in EUDAMED under MDR with this code, the 58 devices are split across classes (as of 8 Sep 2026).

        • 30 Class IIb (51.7%)
        • 28 Class IIa (48.2%)

        Registered in EUDAMED under MDD with this code, the 104 devices are split across classes (as of 8 Sep 2026).

        • 69 Class IIa (66.3%)
        • 35 Class IIb (33.6%)

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

      • R060202Oxygen Administration Humidification SystemsMDR 3 classes · n=80MDD 2 classes · n=71terminal

        Registered in EUDAMED under MDR with this code, the 80 devices are split across classes (as of 8 Sep 2026).

        • 65 Class IIa (81.2%)
        • 9 Class IIb (11.2%)
        • 6 Class I (7.5%)

        Registered in EUDAMED under MDD with this code, the 71 devices are split across classes (as of 8 Sep 2026).

        • 38 Class IIb (53.5%)
        • 33 Class IIa (46.4%)

        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.

      • R060203Inhalation Therapy Humidification LiquidsMDR 3 classes · n=55MDD 97.6% Class IIa · n=86terminal

        Registered in EUDAMED under MDR with this code, the 55 devices are split across classes (as of 8 Sep 2026).

        • 38 Class IIb (69.0%)
        • 9 Class IIa (16.3%)
        • 8 Class I (14.5%)

        Registered in EUDAMED under MDD with this code: 84 of 86 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 84 Class IIa (97.6%)
        • 2 Class I (2.3%)

        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.

      • R060280Humidification Systems - AccessoriesMDR 2 classes · n=123MDD 3 classes · n=40terminal

        Registered in EUDAMED under MDR with this code, the 123 devices are split across classes (as of 8 Sep 2026).

        • 96 Class I (78.0%)
        • 27 Class IIa (21.9%)

        Registered in EUDAMED under MDD with this code, the 40 devices are split across classes (as of 8 Sep 2026).

        • 26 Class IIa (65.0%)
        • 13 Class IIb (32.5%)
        • 1 Class I (2.5%)

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

      • R060299Humidification Systems - OtherMDR 2 classes · n=230MDD 3 classes · n=52terminal

        Registered in EUDAMED under MDR with this code, the 230 devices are split across classes (as of 8 Sep 2026).

        • 131 Class IIa (56.9%)
        • 99 Class I (43.0%)

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

        • 41 Class IIa (78.8%)
        • 9 Class IIb (17.3%)
        • 2 Class I (3.8%)

        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.

    • R0680Nebulisation and Humidification Systems - Accessories not Included in Other ClassesMDR 2 classes · n=115MDD 100.0% Class IIa · n=31terminal

      Registered in EUDAMED under MDR with this code, the 115 devices are split across classes (as of 8 Sep 2026).

      • 77 Class IIa (66.9%)
      • 38 Class I (33.0%)

      Registered in EUDAMED under MDD with this code: 31 of 31 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 31 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.

    • R0699Nebulisation and Humidification Systems - OtherMDR 3 classes · n=77MDD 97.1% Class IIa · n=35terminal

      Registered in EUDAMED under MDR with this code, the 77 devices are split across classes (as of 8 Sep 2026).

      • 68 Class IIa (88.3%)
      • 7 Class I (9.0%)
      • 2 Class IIb (2.5%)

      Registered in EUDAMED under MDD with this code: 34 of 35 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 34 Class IIa (97.1%)
      • 1 Class IIb (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.

How R06 is structured

9
terminal codes, selectable in a device record
2
branch headings, not selectable
5
name a specific device type
44%
fallback entries: Other and Accessories

The Nebulisation and Humidification Systems branch runs 2 levels deep. 2 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 9 codes marked terminal.

2 terminal codes are “- Other” entries and 2 are “- Accessories” entries, 44% 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 R0602 (Humidification Systems), holding 5 of the 9 terminal codes.

Frequently asked questions

Which R06 codes can be used in a EUDAMED device record?
9 of the 11 codes listed under R06 (Nebulisation and Humidification Systems) are terminal and can be selected. The other 2 are branch headings that cannot.
How deep is the R06 hierarchy?
The R06 branch runs 2 levels below the group code. Its largest sub-branch is R0602 (Humidification Systems), which holds 5 of the 9 terminal codes.
How many R06 codes are catch-all entries?
2 terminal codes under R06 are "- Other" entries and 2 are "- Accessories" entries, 44% of the branch. The remaining 5 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 R

R01Intubation DevicesR02Breathing Circuits and Catheter MountsR03Respiratory Masks and Balloons, Single-Use and ReusableR04Respiratory FiltersR05Suction and Dilatation Systems for the Respiratory SystemR07Bronchopulmonary Endoscopy Devices, Single-UseR90Respiratory and Anaesthesia Devices - Various

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.