EMDN X05: High 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 Treatment

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.

• X05High 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 Treatment
  • X0501High 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 Treatment – LaserMDR 2 classes · n=38terminal

    Registered in EUDAMED under MDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).

    • 35 Class IIa (92.1%)
    • 3 Class IIb (7.8%)

    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.

  • X0502High 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 Treatment – Intense Pulsed LightMDR 100.0% Class IIa · n=76terminal

    Registered in EUDAMED under MDR with this code: 76 of 76 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 76 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.

  • X0599High 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 Treatment – OtherMDR 3 classes · n=43terminal

    Registered in EUDAMED under MDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).

    • 33 Class IIb (76.7%)
    • 9 Class I (20.9%)
    • 1 Class IIa (2.3%)

    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.