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.

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.

R06Nebulisation and Humidification Systems
- R0601Nebulisation Systems
  - R060101Cold Nebulisation Systemsterminal
  - R060102Hot Nebulisation Systemsterminal
- R0602Humidification Systems
  - R060201Active Ventilation Humidification Systems,terminal
  - R060202Oxygen Administration Humidification Systemsterminal
  - R060203Inhalation Therapy Humidification Liquidsterminal
  - R060280Humidification Systems - Accessoriesterminal
  - R060299Humidification Systems - Otherterminal
- R0680Nebulisation and Humidification Systems - Accessories not Included in Other Classesterminal
- R0699Nebulisation and Humidification Systems - Otherterminal

How R06 is structured

terminal codes, selectable in a device record

branch headings, not selectable

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.

Classifying more than a handful of devices?

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Other groups in category R

R01Intubation Devices R02Breathing Circuits and Catheter Mounts R03Respiratory Masks and Balloons, Single-Use and Reusable R04Respiratory Filters R05Suction and Dilatation Systems for the Respiratory System R07Bronchopulmonary Endoscopy Devices, Single-Use R90Respiratory 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.