EMDN P06: Breast Implants

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.

• P06Breast Implants
  • P0601Permanent, Non-Expandable Breast Implants
    • P060101Breast Prostheses, Round
      • P06010101Breast Implants, Round, Saline
        • P0601010101Breast Implants, Round, Saline, with Smooth SurfaceMDR 100.0% Class III · n=62terminal

          Registered in EUDAMED under MDR with this code: 62 of 62 devices carry Class III on their registration (as of 8 Sep 2026).

          • 62 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.

        • P0601010102Breast Implants, Round, Saline, with Textured Surfaceterminal
        • P0601010199Breast Implants, Round, Saline - Otherterminal
      • P06010102Breast Implants, Round, Made of Silicone
        • P0601010201Breast Implants, Round, Made of Silicone, with Smooth SurfaceMDR 100.0% Class III · n=614MDD 100.0% Class III · n=633terminal

          Registered in EUDAMED under MDR with this code: 614 of 614 devices carry Class III on their registration (as of 8 Sep 2026).

          • 614 Class III (100.0%)

          Registered in EUDAMED under MDD with this code: 633 of 633 devices carry Class III on their registration (as of 8 Sep 2026).

          • 633 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.

        • P0601010202Breast Implants, Round, Made of Silicone, with Textured SurfaceMDR 100.0% Class III · n=320MDD 100.0% Class III · n=1,311terminal

          Registered in EUDAMED under MDR with this code: 320 of 320 devices carry Class III on their registration (as of 8 Sep 2026).

          • 320 Class III (100.0%)

          Registered in EUDAMED under MDD with this code: 1,311 of 1,311 devices carry Class III on their registration (as of 8 Sep 2026).

          • 1,311 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.

        • P0601010299Breast Implants, Round, Made of Silicone - OtherMDD 2 classes · n=328terminal

          Registered in EUDAMED under MDD with this code, the 328 devices are split across classes (as of 8 Sep 2026).

          • 300 Class III (91.4%)
          • 28 Class I (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.

    • P060102Breast Implants, Anatomic
      • P06010201Breast Implants, Anatomical, Saline
        • P0601020101Breast Implants, Anatomical, Saline, with Smooth Surfaceterminal
        • P0601020102Breast Implants, Anatomical, Saline, with Textured Surfaceterminal
        • P0601020199Breast Implants, Anatomical, Saline - Otherterminal
      • P06010202Breast Implants, Anatomical, Made of Silicone
        • P0601020201Breast Implants, Anatomical, Made of Silicone, with Smooth Surfaceterminal
        • P0601020202Breast Implants, Anatomical, Made of Silicone, with Textured SurfaceMDD 100.0% Class III · n=2,076terminal

          Registered in EUDAMED under MDD with this code: 2,076 of 2,076 devices carry Class III on their registration (as of 8 Sep 2026).

          • 2,076 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.

        • P0601020299Breast Implants, Anatomical, Made of Silicone - OtherMDD 100.0% Class III · n=957terminal

          Registered in EUDAMED under MDD with this code: 957 of 957 devices carry Class III on their registration (as of 8 Sep 2026).

          • 957 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.

    • P060199Breast Implants, Standard - Otherterminal
  • P0602Breast Implants, Expander
    • P060201Breast Implants, Becker TypeMDR 100.0% Class III · n=20terminal

      Registered in EUDAMED under MDR with this code: 20 of 20 devices carry Class III on their registration (as of 8 Sep 2026).

      • 20 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.

    • P060299Breast Implants, Expander - OtherMDD 100.0% Class III · n=534terminal

      Registered in EUDAMED under MDD with this code: 534 of 534 devices carry Class III on their registration (as of 8 Sep 2026).

      • 534 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.

  • P0680Breast Implants - AccessoriesMDR 99.6% Class IIa · n=323terminal

    Registered in EUDAMED under MDR with this code: 322 of 323 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 322 Class IIa (99.6%)
    • 1 Class I (0.3%)

    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.

  • P0699Breast Implants - OtherMDR 2 classes · n=378MDD 99.4% Class IIa · n=173terminal

    Registered in EUDAMED under MDR with this code, the 378 devices are split across classes (as of 8 Sep 2026).

    • 341 Class IIa (90.2%)
    • 37 Class I (9.7%)

    Registered in EUDAMED under MDD with this code: 172 of 173 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 172 Class IIa (99.4%)
    • 1 Class IIb (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.