EMDN S01: Devices for Sterilisation and Packaging (Excluding Cat. D - Z)

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.

• S01Devices for Sterilisation and Packaging (Excluding Cat. D - Z)
  • S0101Sterilisation Pouches
    • S010101Sterilisation Pouches, Paper/Plastic Film
      • S01010101Sterilisation Pouches, Flat, Paper/Plastic FilmMDR 100.0% Class I · n=2,257terminal

        Registered in EUDAMED under MDR with this code: 2,257 of 2,257 devices carry Class I on their registration (as of 8 Sep 2026).

        • 2,257 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.

      • S01010102Sterilisation Pouches, Gusseted, Paper/Plastic FilmMDR 100.0% Class I · n=506terminal

        Registered in EUDAMED under MDR with this code: 506 of 506 devices carry Class I on their registration (as of 8 Sep 2026).

        • 506 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.

    • S010102Sterilisation Pouches, Tyvek/Plastic Film
      • S01010201Flat Sterilisation Pouches, Tyvek/Plastic FilmMDR 100.0% Class I · n=302terminal

        Registered in EUDAMED under MDR with this code: 302 of 302 devices carry Class I on their registration (as of 8 Sep 2026).

        • 302 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.

    • S010103Sterilisation Pouches, Polyethylene
      • S01010301Flat Sterilisation Pouches, PolyethyleneMDD 100.0% Class IIa · n=38terminal

        Registered in EUDAMED under MDD with this code: 38 of 38 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 38 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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • S010199Sterilisation Pouches - OtherMDR 100.0% Class I · n=799terminal

      Registered in EUDAMED under MDR with this code: 799 of 799 devices carry Class I on their registration (as of 8 Sep 2026).

      • 799 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.

  • S0102Sterilisation Reels
    • S010201Sterilisation Reels, Paper/Plastic Film
      • S01020101Flat Sterilisation Reels, Paper/Plastic FilmMDR 100.0% Class I · n=1,267terminal

        Registered in EUDAMED under MDR with this code: 1,267 of 1,267 devices carry Class I on their registration (as of 8 Sep 2026).

        • 1,267 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.

      • S01020102Sterilisation Reels, Gusseted, Paper/Plastic FilmMDR 100.0% Class I · n=458terminal

        Registered in EUDAMED under MDR with this code: 458 of 458 devices carry Class I on their registration (as of 8 Sep 2026).

        • 458 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.

    • S010202Sterilisation Reels, Tyvek/Plastic Film
      • S01020201Flat Sterilisation Reels, Tyvek/Plastic FilmMDR 100.0% Class I · n=342terminal

        Registered in EUDAMED under MDR with this code: 342 of 342 devices carry Class I on their registration (as of 8 Sep 2026).

        • 342 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.

    • S010203Sterilisation Reels, Polyethylene
      • S01020301Flat Sterilisation Reels, PolyethyleneMDR 100.0% Class I · n=50terminal

        Registered in EUDAMED under MDR with this code: 50 of 50 devices carry Class I on their registration (as of 8 Sep 2026).

        • 50 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.

    • S010299Sterilisation Reels - OtherMDR 100.0% Class I · n=147terminal

      Registered in EUDAMED under MDR with this code: 147 of 147 devices carry Class I on their registration (as of 8 Sep 2026).

      • 147 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.

  • S0103Materials for Packaging Packs to Be Sterilized
    • S010301Medical Crepe Paper for SterilisationMDR 100.0% Class I · n=477terminal

      Registered in EUDAMED under MDR with this code: 477 of 477 devices carry Class I on their registration (as of 8 Sep 2026).

      • 477 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.

    • S010302Non-Woven Fabric for SterilisationMDR 100.0% Class I · n=941terminal

      Registered in EUDAMED under MDR with this code: 941 of 941 devices carry Class I on their registration (as of 8 Sep 2026).

      • 941 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.

    • S010399Materials for Packaging Packs to Be Sterilized - OtherMDR 100.0% Class I · n=185terminal

      Registered in EUDAMED under MDR with this code: 185 of 185 devices carry Class I on their registration (as of 8 Sep 2026).

      • 185 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.

  • S0104Containers for Sterilisation
    • S010401Trays, Baskets, Tubs for Sterilisation and Their ComponentsMDR 99.8% Class I · n=31,480MDD 100.0% Class I · n=375terminal

      Registered in EUDAMED under MDR with this code: 31,420 of 31,480 devices carry Class I on their registration (as of 8 Sep 2026).

      • 31,420 Class I (99.8%)
      • 59 Class IIa (0.1%)
      • 1 Class IIb (<0.1%)

      Registered in EUDAMED under MDD with this code: 375 of 375 devices carry Class I on their registration (as of 8 Sep 2026).

      • 375 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.

    • S010402Filters for Sterilisation ContainersMDR 100.0% Class I · n=166terminal

      Registered in EUDAMED under MDR with this code: 166 of 166 devices carry Class I on their registration (as of 8 Sep 2026).

      • 166 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.

    • S010499Sterilisation Containers - OtherMDR 100.0% Class I · n=9,510terminal

      Registered in EUDAMED under MDR with this code: 9,510 of 9,510 devices carry Class I on their registration (as of 8 Sep 2026).

      • 9,510 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.

  • S0199Devices for Sterilisation and Packaging (Excluding Cat. D - Z) - OtherMDR 100.0% Class I · n=658terminal

    Registered in EUDAMED under MDR with this code: 658 of 658 devices carry Class I on their registration (as of 8 Sep 2026).

    • 658 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.