EMDN X01: Contact Lenses or Other Items Intended to Be Introduced Into or Onto the Eye without an Intended Medical Purpose
Complete hierarchy for EMDN group X01 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.
X01Contact Lenses or Other Items Intended to Be Introduced Into or Onto the Eye without an Intended Medical PurposeX0101Contact Lenses without an Intended Medical Purpose – HydrogelX010101Contact Lenses without an Intended Medical Purpose – Hydrogel, Single-UseX01010101Contact Lenses without an Intended Medical Purpose – Hydrogel, Daily Single-UseterminalX01010102Contact Lenses without an Intended Medical Purpose – Hydrogel, Extended Wear Single-Useterminal
X010102Contact Lenses without an Intended Medical Purpose – Hydrogel, Reusableterminal
X0102Contact Lenses without an Intended Medical Purpose – Non Hydrogelterminal
How X01 is structured
The Contact Lenses or Other Items Intended to Be Introduced Into or Onto the Eye without an Intended Medical Purpose branch runs 3 levels deep. 2 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 4 codes marked terminal.
Frequently asked questions
- Which X01 codes can be used in a EUDAMED device record?
- 4 of the 6 codes listed under X01 (Contact Lenses or Other Items Intended to Be Introduced Into or Onto the Eye without an Intended Medical Purpose) are terminal and can be selected. The other 2 are branch headings that cannot.
- How deep is the X01 hierarchy?
- The X01 branch runs 3 levels 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
X02Products 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 PiercingsX03Substances, 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 TattooingX04Equipment 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.