Which R04 codes can be used in a EUDAMED device record?

7 of the 10 codes listed under R04 (Respiratory Filters) are terminal and can be selected. The other 3 are branch headings that cannot.

How deep is the R04 hierarchy?

The R04 branch runs 2 levels below the group code. Its largest sub-branch is R0401 (Ventilation Filters), which holds 3 of the 7 terminal codes.

How many R04 codes are catch-all entries?

3 terminal codes under R04 are "- Other" entries, 43% of the branch. The remaining 4 name a specific device type.

EMDN R04: Respiratory Filters

Complete hierarchy for EMDN group R04 in category R (Respiratory and Anaesthesia Devices): 7 terminal codes, EMDN v2026. Terminal codes are the ones accepted in a EUDAMED device record.

R04Respiratory Filters
- R0401Ventilation Filters
  - R040101Antibacterial and Antiviral Respiratory Filtersterminal
  - R040102Antibacterial and Antiviral Respiratory Filters Humidifiersterminal
  - R040199Ventilation Filters - Otherterminal
- R0402Natural Breathing Filters
  - R040201Tracheostomy Humidifiersterminal
  - R040299Natural Breathing Filters - Otherterminal
- R0490Respiratory Filters - Various
  - R049001Pulmonary Function Test Filtersterminal
- R0499Respiratory Filters - Otherterminal

How R04 is structured

terminal codes, selectable in a device record

branch headings, not selectable

name a specific device type

43%

fallback entries: Other and Accessories

The Respiratory Filters branch runs 2 levels deep. 3 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 7 codes marked terminal.

3 terminal codes are “- Other” entries, 43% 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 R0401 (Ventilation Filters), holding 3 of the 7 terminal codes.

Frequently asked questions

Which R04 codes can be used in a EUDAMED device record?: 7 of the 10 codes listed under R04 (Respiratory Filters) are terminal and can be selected. The other 3 are branch headings that cannot.
How deep is the R04 hierarchy?: The R04 branch runs 2 levels below the group code. Its largest sub-branch is R0401 (Ventilation Filters), which holds 3 of the 7 terminal codes.
How many R04 codes are catch-all entries?: 3 terminal codes under R04 are "- Other" entries, 43% of the branch. The remaining 4 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 R05Suction and Dilatation Systems for the Respiratory System R06Nebulisation and Humidification Systems 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.