EMDN X03: Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, Excluding Those for Tattooing
Complete hierarchy for EMDN group X03 in category X (Products without an Intended Medical Purpose (Annex XVI)): 4 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.
X03Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, Excluding Those for TattooingX0301Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, Excluding Those for Tattooing – ResorbableterminalX0302Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, Excluding Those for Tattooing – Non ResorbableterminalX0303Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, by A Prefilled Means for Introduction, Excluding Those for Tattooing – ResorbableMDR 100.0% Class III · n=33MDD 100.0% Class III · n=276terminalRegistered in EUDAMED under MDR with this code: 33 of 33 devices carry Class III on their registration (as of 8 Sep 2026).
- 33 Class III (100.0%)
Registered in EUDAMED under MDD with this code: 276 of 276 devices carry Class III on their registration (as of 8 Sep 2026).
- 276 Class III (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.
X0304Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, by A Prefilled Means for Introduction, Excluding Those for Tattooing – Non Resorbableterminal
How X03 is structured
The Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, Excluding Those for Tattooing branch runs 1 level deep. Every code below is terminal.
Frequently asked questions
- Which X03 codes can be used in a EUDAMED device record?
- All 4 codes listed under X03 (Substances, Combinations of Substances, or Items without an Intended Medical Purpose Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous or Intradermal Injection or Other Introduction, Excluding Those for Tattooing) are terminal, so any of them can be selected in a device record.
- How deep is the X03 hierarchy?
- The X03 branch runs 1 level below the group code.
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 CheckOther groups in category X
X01Contact Lenses or Other Items Intended to Be Introduced Into or Onto the Eye without an Intended Medical PurposeX02Products without an Intended Medical Purpose Intended to Be Totally or Partially Introduced Into the Human Body Through Surgically Invasive Means for the Purpose of Modifying the Anatomy or Fixation of Body Parts with the Exception of Tattooing Products and PiercingsX04Equipment without an Intended Medical Purpose Intended to Be Used to Reduce, Remove or Destroy Adipose TissueX05High Intensity Electromagnetic Radiation Emitting Equipment without an Intended Medical Purpose Intended for Use on the Human Body for Skin Resurfacing, Tattoo or Hair Removal or Other Skin TreatmentX06Equipment without an Intended Medical Purpose Intended for Brain Stimulation That Apply Electrical Currents or Magnetic or Electromagnetic Fields That Penetrate the Cranium to Modify Neuronal Activity in the BrainSource: 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.