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.
R03Respiratory Masks and Balloons, Single-Use and ReusableR0301Respiratory MasksR030101Ventilation MasksR03010101Anaesthetic Face MasksterminalR03010102Cpap and Niv MasksR0301010201Cpap MasksterminalR0301010202Niv Masksterminal
R03010104Cpap and Niv Helmets and KitsR0301010401Cpap Helmets and KitsterminalR0301010402Niv Helmets and Kitsterminal
R03010180Artificial Ventilation Masks - AccessoriesterminalR03010199Ventilation Masks - Otherterminal
R030102Air/Oxygen Masks and Nasal CannulasR03010201Air/Oxygen MasksterminalR03010202Venturi MasksterminalR03010203Oxygen Therapy Nasal CannulasR0301020301Oxygen Therapy Standard Nasal Cannulas (Goggles)terminalR0301020302High Flow Therapy Nasal Cannulas (Hfnc)terminal
R03010204Oxygen Administration TubingsterminalR03010205Tracheostomy O2 SuppliersterminalR03010206Masks with ReservoirterminalR03010207Oxygen Therapy KitsterminalR03010280Oxygen Therapy Masks and Nasal Cannulas - AccessoriesterminalR03010299Oxygen Therapy Masks and Nasal Cannulas - Otherterminal
R030103Aerosol Therapy Masks and SystemsR03010301Aerosol Therapy MasksterminalR03010302Aerosol Portable InhalersterminalR03010303Aerosol Therapy TubingsterminalR03010304Aerosol Therapy KitsterminalR03010380Aerosol Therapy Systems - AccessoriesterminalR03010399Aerosol Therapy Systems - Otherterminal
R030180Respiratory Masks - Accessories not Included in Other ClassesterminalR030199Respiratory Masks - Otherterminal
R0302Respiratory BalloonsR030201Ventilation BalloonsR03020101Anaesthesia BalloonsterminalR03020102Cpap BalloonsterminalR03020199Ventilation Balloons - Otherterminal
R030202Manually Operated Ventilation BalloonsR03020201Manually Operated Pulmonary ResuscitatorsterminalR03020202Self-Inflating Ventilation Balloonsterminal
R030280Respiratory Ballons - AccessoriesterminalR030299Respiratory Balloons - Otherterminal
How R03 is structured
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.
Classifying more than a handful of devices?
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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.