Which R03 codes can be used in a EUDAMED device record?

32 of the 42 codes listed under R03 (Respiratory Masks and Balloons, Single-Use and Reusable) are terminal and can be selected. The other 10 are branch headings that cannot.

How deep is the R03 hierarchy?

The R03 branch runs 4 levels below the group code. Its largest sub-branch is R0301 (Respiratory Masks), which holds 25 of the 32 terminal codes.

How many R03 codes are catch-all entries?

6 terminal codes under R03 are "- Other" entries and 5 are "- Accessories" entries, 34% of the branch. The remaining 21 name a specific device type.

EMDN R03: Respiratory Masks and Balloons, Single-Use and Reusable

Complete hierarchy for EMDN group R03 in category R (Respiratory and Anaesthesia Devices): 32 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.

R03Respiratory Masks and Balloons, Single-Use and Reusable
- R0301Respiratory Masks
  - R030101Ventilation Masks
    - R03010101Anaesthetic Face MasksMDR 95.1% Class IIa · n=941MDD 100.0% Class IIa · n=361terminal
      Registered in EUDAMED under MDR with this code: 895 of 941 devices carry Class IIa on their registration (as of 8 Sep 2026).
      895 Class IIa (95.1%)
      46 Class I (4.8%)
      Registered in EUDAMED under MDD with this code: 361 of 361 devices carry Class IIa on their registration (as of 8 Sep 2026).
      361 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.
    - R03010102Cpap and Niv Masks
      - R0301010201Cpap MasksMDR 98.5% Class IIa · n=546MDD 99.4% Class IIa · n=190terminal
        Registered in EUDAMED under MDR with this code: 538 of 546 devices carry Class IIa on their registration (as of 8 Sep 2026).
        538 Class IIa (98.5%)
        8 Class I (1.4%)
        Registered in EUDAMED under MDD with this code: 189 of 190 devices carry Class IIa on their registration (as of 8 Sep 2026).
        189 Class IIa (99.4%)
        1 Class III (0.5%)
        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.
      - R0301010202Niv MasksMDR 96.0% Class IIa · n=276MDD 100.0% Class IIa · n=176terminal
        Registered in EUDAMED under MDR with this code: 265 of 276 devices carry Class IIa on their registration (as of 8 Sep 2026).
        265 Class IIa (96.0%)
        11 Class I (3.9%)
        Registered in EUDAMED under MDD with this code: 176 of 176 devices carry Class IIa on their registration (as of 8 Sep 2026).
        176 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.
    - R03010104Cpap and Niv Helmets and Kits
      - R0301010401Cpap Helmets and KitsMDR 2 classes · n=74terminal
        Registered in EUDAMED under MDR with this code, the 74 devices are split across classes (as of 8 Sep 2026).
        61 Class IIa (82.4%)
        13 Class I (17.5%)
        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.
      - R0301010402Niv Helmets and KitsMDR 98.0% Class IIa · n=50terminal
        Registered in EUDAMED under MDR with this code: 49 of 50 devices carry Class IIa on their registration (as of 8 Sep 2026).
        49 Class IIa (98.0%)
        1 Class I (2.0%)
        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.
    - R03010180Artificial Ventilation Masks - AccessoriesMDR 2 classes · n=72MDD 100.0% Class IIa · n=48terminal
      Registered in EUDAMED under MDR with this code, the 72 devices are split across classes (as of 8 Sep 2026).
      64 Class I (88.8%)
      8 Class IIa (11.1%)
      Registered in EUDAMED under MDD with this code: 48 of 48 devices carry Class IIa on their registration (as of 8 Sep 2026).
      48 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.
    - R03010199Ventilation Masks - OtherMDR 2 classes · n=292MDD 99.3% Class IIa · n=304terminal
      Registered in EUDAMED under MDR with this code, the 292 devices are split across classes (as of 8 Sep 2026).
      182 Class IIa (62.3%)
      110 Class I (37.6%)
      Registered in EUDAMED under MDD with this code: 302 of 304 devices carry Class IIa on their registration (as of 8 Sep 2026).
      302 Class IIa (99.3%)
      2 Class I (0.6%)
      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.
  - R030102Air/Oxygen Masks and Nasal Cannulas
    - R03010201Air/Oxygen MasksMDR 97.0% Class IIa · n=638MDD 97.9% Class IIa · n=348terminal
      Registered in EUDAMED under MDR with this code: 619 of 638 devices carry Class IIa on their registration (as of 8 Sep 2026).
      619 Class IIa (97.0%)
      18 Class I (2.8%)
      1 Class III (0.1%)
      Registered in EUDAMED under MDD with this code: 341 of 348 devices carry Class IIa on their registration (as of 8 Sep 2026).
      341 Class IIa (97.9%)
      6 Class I (1.7%)
      1 Class III (0.2%)
      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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - R03010202Venturi MasksMDR 100.0% Class IIa · n=101MDD 100.0% Class IIa · n=290terminal
      Registered in EUDAMED under MDR with this code: 101 of 101 devices carry Class IIa on their registration (as of 8 Sep 2026).
      101 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 290 of 290 devices carry Class IIa on their registration (as of 8 Sep 2026).
      290 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.
    - R03010203Oxygen Therapy Nasal Cannulas
      - R0301020301Oxygen Therapy Standard Nasal Cannulas (Goggles)MDR 99.7% Class IIa · n=913MDD 99.5% Class IIa · n=211terminal
        Registered in EUDAMED under MDR with this code: 911 of 913 devices carry Class IIa on their registration (as of 8 Sep 2026).
        911 Class IIa (99.7%)
        2 Class I (0.2%)
        Registered in EUDAMED under MDD with this code: 210 of 211 devices carry Class IIa on their registration (as of 8 Sep 2026).
        210 Class IIa (99.5%)
        1 Class I (0.4%)
        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.
      - R0301020302High Flow Therapy Nasal Cannulas (Hfnc)MDR 100.0% Class IIa · n=155MDD 99.4% Class IIa · n=189terminal
        Registered in EUDAMED under MDR with this code: 155 of 155 devices carry Class IIa on their registration (as of 8 Sep 2026).
        155 Class IIa (100.0%)
        Registered in EUDAMED under MDD with this code: 188 of 189 devices carry Class IIa on their registration (as of 8 Sep 2026).
        188 Class IIa (99.4%)
        1 Class I (0.5%)
        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.
    - R03010204Oxygen Administration TubingsMDR 2 classes · n=218MDD 100.0% Class IIa · n=97terminal
      Registered in EUDAMED under MDR with this code, the 218 devices are split across classes (as of 8 Sep 2026).
      204 Class IIa (93.5%)
      14 Class I (6.4%)
      Registered in EUDAMED under MDD with this code: 97 of 97 devices carry Class IIa on their registration (as of 8 Sep 2026).
      97 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.
    - R03010205Tracheostomy O2 SuppliersMDD 100.0% Class IIa · n=20terminal
      Registered in EUDAMED under MDD with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
      20 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.
    - R03010206Masks with ReservoirMDR 100.0% Class IIa · n=55MDD 100.0% Class IIa · n=20terminal
      Registered in EUDAMED under MDR with this code: 55 of 55 devices carry Class IIa on their registration (as of 8 Sep 2026).
      55 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
      20 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.
    - R03010207Oxygen Therapy KitsMDD 97.2% Class IIa · n=37terminal
      Registered in EUDAMED under MDD with this code: 36 of 37 devices carry Class IIa on their registration (as of 8 Sep 2026).
      36 Class IIa (97.2%)
      1 Class IIb (2.7%)
      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.
    - R03010280Oxygen Therapy Masks and Nasal Cannulas - AccessoriesMDR 2 classes · n=92MDD 100.0% Class IIa · n=40terminal
      Registered in EUDAMED under MDR with this code, the 92 devices are split across classes (as of 8 Sep 2026).
      65 Class I (70.6%)
      27 Class IIa (29.3%)
      Registered in EUDAMED under MDD with this code: 40 of 40 devices carry Class IIa on their registration (as of 8 Sep 2026).
      40 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.
    - R03010299Oxygen Therapy Masks and Nasal Cannulas - OtherMDR 2 classes · n=86MDD 100.0% Class IIa · n=42terminal
      Registered in EUDAMED under MDR with this code, the 86 devices are split across classes (as of 8 Sep 2026).
      49 Class IIa (56.9%)
      37 Class I (43.0%)
      Registered in EUDAMED under MDD with this code: 42 of 42 devices carry Class IIa on their registration (as of 8 Sep 2026).
      42 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.
  - R030103Aerosol Therapy Masks and Systems
    - R03010301Aerosol Therapy MasksMDR 3 classes · n=268MDD 100.0% Class IIa · n=79terminal
      Registered in EUDAMED under MDR with this code, the 268 devices are split across classes (as of 8 Sep 2026).
      238 Class IIa (88.8%)
      25 Class I (9.3%)
      5 Class IIb (1.8%)
      Registered in EUDAMED under MDD with this code: 79 of 79 devices carry Class IIa on their registration (as of 8 Sep 2026).
      79 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.
    - R03010302Aerosol Portable InhalersMDR 3 classes · n=212MDD 95.6% Class I · n=46terminal
      Registered in EUDAMED under MDR with this code, the 212 devices are split across classes (as of 8 Sep 2026).
      116 Class IIa (54.7%)
      89 Class I (41.9%)
      7 Class IIb (3.3%)
      Registered in EUDAMED under MDD with this code: 44 of 46 devices carry Class I on their registration (as of 8 Sep 2026).
      44 Class I (95.6%)
      2 Class IIa (4.3%)
      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.
    - R03010303Aerosol Therapy Tubingsterminal
    - R03010304Aerosol Therapy KitsMDR 100.0% Class IIa · n=176MDD 100.0% Class IIa · n=91terminal
      Registered in EUDAMED under MDR with this code: 176 of 176 devices carry Class IIa on their registration (as of 8 Sep 2026).
      176 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 91 of 91 devices carry Class IIa on their registration (as of 8 Sep 2026).
      91 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.
    - R03010380Aerosol Therapy Systems - AccessoriesMDR 2 classes · n=256MDD 2 classes · n=47terminal
      Registered in EUDAMED under MDR with this code, the 256 devices are split across classes (as of 8 Sep 2026).
      143 Class I (55.8%)
      113 Class IIa (44.1%)
      Registered in EUDAMED under MDD with this code, the 47 devices are split across classes (as of 8 Sep 2026).
      43 Class IIb (91.4%)
      4 Class IIa (8.5%)
      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.
    - R03010399Aerosol Therapy Systems - Otherterminal
  - R030180Respiratory Masks - Accessories not Included in Other ClassesMDR 97.2% Class I · n=74terminal
    Registered in EUDAMED under MDR with this code: 72 of 74 devices carry Class I on their registration (as of 8 Sep 2026).
    72 Class I (97.2%)
    2 Class IIa (2.7%)
    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.
  - R030199Respiratory Masks - OtherMDR 2 classes · n=257terminal
    Registered in EUDAMED under MDR with this code, the 257 devices are split across classes (as of 8 Sep 2026).
    164 Class I (63.8%)
    93 Class IIa (36.1%)
    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.
- R0302Respiratory Balloons
  - R030201Ventilation Balloons
    - R03020101Anaesthesia BalloonsMDR 2 classes · n=97MDD 2 classes · n=56terminal
      Registered in EUDAMED under MDR with this code, the 97 devices are split across classes (as of 8 Sep 2026).
      90 Class IIa (92.7%)
      7 Class I (7.2%)
      Registered in EUDAMED under MDD with this code, the 56 devices are split across classes (as of 8 Sep 2026).
      52 Class IIa (92.8%)
      4 Class I (7.1%)
      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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - R03020102Cpap Balloonsterminal
    - R03020199Ventilation Balloons - OtherMDR 2 classes · n=113terminal
      Registered in EUDAMED under MDR with this code, the 113 devices are split across classes (as of 8 Sep 2026).
      91 Class IIa (80.5%)
      22 Class I (19.4%)
      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.
  - R030202Manually Operated Ventilation Balloons
    - R03020201Manually Operated Pulmonary ResuscitatorsMDR 96.7% Class IIa · n=1,016MDD 96.7% Class IIa · n=248terminal
      Registered in EUDAMED under MDR with this code: 983 of 1,016 devices carry Class IIa on their registration (as of 8 Sep 2026).
      983 Class IIa (96.7%)
      29 Class I (2.8%)
      4 Class IIb (0.3%)
      Registered in EUDAMED under MDD with this code: 240 of 248 devices carry Class IIa on their registration (as of 8 Sep 2026).
      240 Class IIa (96.7%)
      4 Class I (1.6%)
      4 Class IIb (1.6%)
      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.
    - R03020202Self-Inflating Ventilation Balloonsterminal
  - R030280Respiratory Ballons - AccessoriesMDR 2 classes · n=29terminal
    Registered in EUDAMED under MDR with this code, the 29 devices are split across classes (as of 8 Sep 2026).
    27 Class IIa (93.1%)
    2 Class I (6.8%)
    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.
  - R030299Respiratory Balloons - OtherMDD 100.0% Class IIa · n=163terminal
    Registered in EUDAMED under MDD with this code: 163 of 163 devices carry Class IIa on their registration (as of 8 Sep 2026).
    163 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.

How R03 is structured

terminal codes, selectable in a device record

branch headings, not selectable

name a specific device type

34%

fallback entries: Other and Accessories

The Respiratory Masks and Balloons, Single-Use and Reusable branch runs 4 levels deep. 10 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 32 codes marked terminal.

6 terminal codes are “- Other” entries and 5 are “- Accessories” entries, 34% 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 R0301 (Respiratory Masks), holding 25 of the 32 terminal codes.

Frequently asked questions

Which R03 codes can be used in a EUDAMED device record?: 32 of the 42 codes listed under R03 (Respiratory Masks and Balloons, Single-Use and Reusable) are terminal and can be selected. The other 10 are branch headings that cannot.
How deep is the R03 hierarchy?: The R03 branch runs 4 levels below the group code. Its largest sub-branch is R0301 (Respiratory Masks), which holds 25 of the 32 terminal codes.
How many R03 codes are catch-all entries?: 6 terminal codes under R03 are "- Other" entries and 5 are "- Accessories" entries, 34% of the branch. The remaining 21 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.

Run a free Readiness Check

Other groups in category R

R01Intubation Devices R02Breathing Circuits and Catheter Mounts R04Respiratory Filters 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.