EMDN T02: Protective Clothing and Drapes (Excluding Personal Protective Equipment - PPE)

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.

• T02Protective Clothing and Drapes (Excluding Personal Protective Equipment - PPE)
  • T0201Surgical Drapes
    • T020101Incision Drapes
      • T02010101Incision Drapes, without Antibacterial AgentMDR 100.0% Class I · n=1,688MDD 96.4% Class I · n=57terminal

        Registered in EUDAMED under MDR with this code: 1,688 of 1,688 devices carry Class I on their registration (as of 8 Sep 2026).

        • 1,688 Class I (100.0%)

        Registered in EUDAMED under MDD with this code: 55 of 57 devices carry Class I on their registration (as of 8 Sep 2026).

        • 55 Class I (96.4%)
        • 2 Class IIa (3.5%)

        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.

      • T02010102Incision Drapes, with Antibacterial AgentMDR 95.0% Class I · n=120terminal

        Registered in EUDAMED under MDR with this code: 114 of 120 devices carry Class I on their registration (as of 8 Sep 2026).

        • 114 Class I (95.0%)
        • 6 Class III (5.0%)

        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.

    • T020102Specialistic Surgery DrapesMDR 99.8% Class I · n=4,169MDD 100.0% Class I · n=202terminal

      Registered in EUDAMED under MDR with this code: 4,162 of 4,169 devices carry Class I on their registration (as of 8 Sep 2026).

      • 4,162 Class I (99.8%)
      • 7 Class IIa (0.1%)

      Registered in EUDAMED under MDD with this code: 202 of 202 devices carry Class I on their registration (as of 8 Sep 2026).

      • 202 Class I (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.

    • T020103Surgical Thermal DrapesMDR 95.6% Class I · n=46terminal

      Registered in EUDAMED under MDR with this code: 44 of 46 devices carry Class I on their registration (as of 8 Sep 2026).

      • 44 Class I (95.6%)
      • 2 Class IIb (4.3%)

      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.

    • T020199Surgical Drapes - OtherMDR 99.9% Class I · n=6,657MDD 98.7% Class I · n=576terminal

      Registered in EUDAMED under MDR with this code: 6,655 of 6,657 devices carry Class I on their registration (as of 8 Sep 2026).

      • 6,655 Class I (99.9%)
      • 2 Class IIa (<0.1%)

      Registered in EUDAMED under MDD with this code: 569 of 576 devices carry Class I on their registration (as of 8 Sep 2026).

      • 569 Class I (98.7%)
      • 6 Class IIa (1.0%)
      • 1 Class IIb (0.1%)

      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.

  • T0202Surgical Procedural Kits (Excluding Surgical Instrument Kits)MDR 4 classes · n=22,897MDD 3 classes · n=638terminal

    Registered in EUDAMED under MDR with this code, the 22,897 devices are split across classes (as of 8 Sep 2026).

    • 13,065 Class IIa (57.0%)
    • 6,710 Class I (29.3%)
    • 2,282 Class IIb (9.9%)
    • 840 Class III (3.6%)

    Registered in EUDAMED under MDD with this code, the 638 devices are split across classes (as of 8 Sep 2026).

    • 405 Class IIa (63.4%)
    • 225 Class I (35.2%)
    • 8 Class IIb (1.2%)

    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.

  • T0203Dressing and Assistance KitsMDR 4 classes · n=1,380MDD 95.8% Class I · n=72terminal

    Registered in EUDAMED under MDR with this code, the 1,380 devices are split across classes (as of 8 Sep 2026).

    • 831 Class I (60.2%)
    • 535 Class IIa (38.7%)
    • 10 Class IIb (0.7%)
    • 4 Class III (0.2%)

    Registered in EUDAMED under MDD with this code: 69 of 72 devices carry Class I on their registration (as of 8 Sep 2026).

    • 69 Class I (95.8%)
    • 3 Class IIa (4.1%)

    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.

  • T0204Surgical Gowns (Excluding Personal Protective Equipment - PPE)
    • T020401Standard Surgical GownsMDR 100.0% Class I · n=3,110MDD 100.0% Class I · n=167terminal

      Registered in EUDAMED under MDR with this code: 3,110 of 3,110 devices carry Class I on their registration (as of 8 Sep 2026).

      • 3,110 Class I (100.0%)

      Registered in EUDAMED under MDD with this code: 167 of 167 devices carry Class I on their registration (as of 8 Sep 2026).

      • 167 Class I (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.

    • T020402Reinforced Surgical GownsMDR 100.0% Class I · n=2,282MDD 100.0% Class I · n=94terminal

      Registered in EUDAMED under MDR with this code: 2,282 of 2,282 devices carry Class I on their registration (as of 8 Sep 2026).

      • 2,282 Class I (100.0%)

      Registered in EUDAMED under MDD with this code: 94 of 94 devices carry Class I on their registration (as of 8 Sep 2026).

      • 94 Class I (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.

    • T020499Surgical Gowns - OtherMDR 100.0% Class I · n=707terminal

      Registered in EUDAMED under MDR with this code: 707 of 707 devices carry Class I on their registration (as of 8 Sep 2026).

      • 707 Class I (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.

  • T0205Non-Surgical Gowns (Excluding Personal Protective Equipment - PPE)MDR 100.0% Class I · n=2,291MDD 100.0% Class I · n=24terminal

    Registered in EUDAMED under MDR with this code: 2,291 of 2,291 devices carry Class I on their registration (as of 8 Sep 2026).

    • 2,291 Class I (100.0%)

    Registered in EUDAMED under MDD with this code: 24 of 24 devices carry Class I on their registration (as of 8 Sep 2026).

    • 24 Class I (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.

  • T0206Medical Use Face Masks (Excluding Personal Protective Equipment - PPE)
    • T020603Medical Use Face Masks, Type I (not for Healthcare Professionals)MDR 100.0% Class I · n=234terminal

      Registered in EUDAMED under MDR with this code: 234 of 234 devices carry Class I on their registration (as of 8 Sep 2026).

      • 234 Class I (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.

    • T020604Medical Use Face Masks, Type Ii and IirMDR 99.8% Class I · n=3,203terminal

      Registered in EUDAMED under MDR with this code: 3,198 of 3,203 devices carry Class I on their registration (as of 8 Sep 2026).

      • 3,198 Class I (99.8%)
      • 5 Class IIa (0.1%)

      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.

    • T020699Medical Use Face Masks (Excluding Personal Protective Equipment - PPE) - OtherMDR 99.8% Class I · n=681terminal

      Registered in EUDAMED under MDR with this code: 680 of 681 devices carry Class I on their registration (as of 8 Sep 2026).

      • 680 Class I (99.8%)
      • 1 Class IIa (0.1%)

      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.

  • T0207Caps and Headwear (Excluding Personal Protective Equipment - PPE)MDR 100.0% Class I · n=1,571terminal

    Registered in EUDAMED under MDR with this code: 1,571 of 1,571 devices carry Class I on their registration (as of 8 Sep 2026).

    • 1,571 Class I (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.

  • T0208Shoe Covers (Excluding Personal Protective Equipment - PPE)MDR 100.0% Class I · n=659terminal

    Registered in EUDAMED under MDR with this code: 659 of 659 devices carry Class I on their registration (as of 8 Sep 2026).

    • 659 Class I (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.

  • T0209Surgical Aprons (Excluding Personal Protective Equipment - PPE)MDR 100.0% Class I · n=230terminal

    Registered in EUDAMED under MDR with this code: 230 of 230 devices carry Class I on their registration (as of 8 Sep 2026).

    • 230 Class I (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.

  • T0210Non-Surgical DrapesMDR 100.0% Class I · n=463terminal

    Registered in EUDAMED under MDR with this code: 463 of 463 devices carry Class I on their registration (as of 8 Sep 2026).

    • 463 Class I (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.

  • T0299Protection Drapes and Garments - OtherMDR 100.0% Class I · n=6,663terminal

    Registered in EUDAMED under MDR with this code: 6,663 of 6,663 devices carry Class I on their registration (as of 8 Sep 2026).

    • 6,663 Class I (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.