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.

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.

  • R04Respiratory Filters
    • R0401Ventilation Filters
      • R040101Antibacterial and Antiviral Respiratory FiltersMDR 97.0% Class IIa · n=305MDD 2 classes · n=457terminal

        Registered in EUDAMED under MDR with this code: 296 of 305 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 296 Class IIa (97.0%)
        • 9 Class I (2.9%)

        Registered in EUDAMED under MDD with this code, the 457 devices are split across classes (as of 8 Sep 2026).

        • 399 Class IIa (87.3%)
        • 58 Class I (12.6%)

        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.

      • R040102Antibacterial and Antiviral Respiratory Filters HumidifiersMDR 99.5% Class IIa · n=444MDD 2 classes · n=180terminal

        Registered in EUDAMED under MDR with this code: 442 of 444 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 442 Class IIa (99.5%)
        • 2 Class I (0.4%)

        Registered in EUDAMED under MDD with this code, the 180 devices are split across classes (as of 8 Sep 2026).

        • 166 Class IIa (92.2%)
        • 14 Class I (7.7%)

        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.

      • R040199Ventilation Filters - OtherMDR 2 classes · n=568terminal

        Registered in EUDAMED under MDR with this code, the 568 devices are split across classes (as of 8 Sep 2026).

        • 487 Class IIa (85.7%)
        • 81 Class I (14.2%)

        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.

    • R0402Natural Breathing Filters
      • R040201Tracheostomy HumidifiersMDR 2 classes · n=205MDD 100.0% Class IIa · n=107terminal

        Registered in EUDAMED under MDR with this code, the 205 devices are split across classes (as of 8 Sep 2026).

        • 179 Class IIa (87.3%)
        • 26 Class I (12.6%)

        Registered in EUDAMED under MDD with this code: 107 of 107 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 107 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.

      • R040299Natural Breathing Filters - OtherMDD 98.4% Class IIa · n=65terminal

        Registered in EUDAMED under MDD with this code: 64 of 65 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 64 Class IIa (98.4%)
        • 1 Class I (1.5%)

        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.

    • R0490Respiratory Filters - Various
      • R049001Pulmonary Function Test FiltersMDR 2 classes · n=124terminal

        Registered in EUDAMED under MDR with this code, the 124 devices are split across classes (as of 8 Sep 2026).

        • 110 Class IIa (88.7%)
        • 14 Class I (11.2%)

        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.

    • R0499Respiratory Filters - OtherMDR 2 classes · n=331terminal

      Registered in EUDAMED under MDR with this code, the 331 devices are split across classes (as of 8 Sep 2026).

      • 306 Class I (92.4%)
      • 25 Class IIa (7.5%)

      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.

How R04 is structured

7
terminal codes, selectable in a device record
3
branch headings, not selectable
4
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.

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 ReusableR05Suction and Dilatation Systems for the Respiratory SystemR06Nebulisation and Humidification SystemsR07Bronchopulmonary 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.