EMDN Q03: ENT Devices

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.

• Q03ENT Devices
  • Q0301Nasopharyngeal Devices
    • Q030101Turbinate Reduction Devices
      • Q03010101Radiofrequency Turbinate Reduction Devicesterminal
      • Q03010199Devices for Turbinate Reduction - Otherterminal
    • Q030102Antisnoring and Obstructive Sleep Apnoea Devices
      • Q03010201Radiofrequency Antisnoring and Obstructive Sleep Apnoea DevicesMDR 97.5% Class IIa · n=41terminal

        Registered in EUDAMED under MDR with this code: 40 of 41 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 40 Class IIa (97.5%)
        • 1 Class I (2.4%)

        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.

      • Q03010299Antisnoring and Obstructive Sleep Apnoea Devices - OtherMDR 3 classes · n=501MDD 2 classes · n=63terminal

        Registered in EUDAMED under MDR with this code, the 501 devices are split across classes (as of 8 Sep 2026).

        • 438 Class I (87.4%)
        • 62 Class IIa (12.3%)
        • 1 Class IIb (0.1%)

        Registered in EUDAMED under MDD with this code, the 63 devices are split across classes (as of 8 Sep 2026).

        • 58 Class IIa (92.0%)
        • 5 Class I (7.9%)

        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.

    • Q030103Nasal Irrigation SolutionsMDR 3 classes · n=1,102MDD 4 classes · n=706terminal

      Registered in EUDAMED under MDR with this code, the 1,102 devices are split across classes (as of 8 Sep 2026).

      • 733 Class IIa (66.5%)
      • 350 Class I (31.7%)
      • 19 Class IIb (1.7%)

      Registered in EUDAMED under MDD with this code, the 706 devices are split across classes (as of 8 Sep 2026).

      • 352 Class I (49.8%)
      • 341 Class IIa (48.3%)
      • 8 Class III (1.1%)
      • 5 Class IIb (0.7%)

      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.

    • Q030199Nasopharyngeal Devices - OtherMDR 3 classes · n=1,024MDD 2 classes · n=269terminal

      Registered in EUDAMED under MDR with this code, the 1,024 devices are split across classes (as of 8 Sep 2026).

      • 545 Class I (53.2%)
      • 445 Class IIa (43.4%)
      • 34 Class IIb (3.3%)

      Registered in EUDAMED under MDD with this code, the 269 devices are split across classes (as of 8 Sep 2026).

      • 161 Class IIa (59.8%)
      • 108 Class I (40.1%)

      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.

  • Q0302Epistaxis Devices
    • Q030201Epistaxis CathetersMDD 2 classes · n=35terminal

      Registered in EUDAMED under MDD with this code, the 35 devices are split across classes (as of 8 Sep 2026).

      • 33 Class I (94.2%)
      • 2 Class IIa (5.7%)

      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.

    • Q030299Epistaxis Devices - OtherMDR 2 classes · n=85terminal

      Registered in EUDAMED under MDR with this code, the 85 devices are split across classes (as of 8 Sep 2026).

      • 70 Class I (82.3%)
      • 15 Class IIb (17.6%)

      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.

  • Q0303ENT Surgery Instruments, Single-Use
    • Q030301ENT Surgery Blades, Single-UseMDR 100.0% Class IIa · n=52terminal

      Registered in EUDAMED under MDR with this code: 52 of 52 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 52 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.

    • Q030302ENT Surgery Burs and Handpieces, Single-UseMDR 100.0% Class IIa · n=121MDD 99.1% Class IIa · n=112terminal

      Registered in EUDAMED under MDR with this code: 121 of 121 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 121 Class IIa (100.0%)

      Registered in EUDAMED under MDD with this code: 111 of 112 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 111 Class IIa (99.1%)
      • 1 Class IIb (0.8%)

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

    • Q030303Nasal Mirrors, Single-Useterminal
    • Q030304ENT Surgery Forceps, Single-UseMDR 2 classes · n=33terminal

      Registered in EUDAMED under MDR with this code, the 33 devices are split across classes (as of 8 Sep 2026).

      • 21 Class I (63.6%)
      • 12 Class IIa (36.3%)

      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.

    • Q030305ENT Surgery Scissors, Single-Useterminal
    • Q030306ENT Surgery Curettes, Single-Useterminal
    • Q030307ENT Surgery Dissectors, Single-Useterminal
    • Q030308ENT Surgery Dilators, Single-Useterminal
    • Q030309Adenotomes, Single-Useterminal
    • Q030310ENT Surgery Hooks, Single-Useterminal
    • Q030311ENT Surgery Rasps and Files, Single-UseMDD 100.0% Class IIa · n=77terminal

      Registered in EUDAMED under MDD with this code: 77 of 77 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 77 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.

    • Q030312ENT Surgery Spatulas, Single-UseMDD 100.0% Class I · n=27terminal

      Registered in EUDAMED under MDD with this code: 27 of 27 devices carry Class I on their registration (as of 8 Sep 2026).

      • 27 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.

    • Q030313ENT Surgery Probes, Single-Useterminal
    • Q030314ENT Surgery Spoons, Single-Useterminal
    • Q030315ENT Surgery Manipulators, Single-Useterminal
    • Q030316ENT Surgery Instrument Kits not Included in Other Classes, Single-Useterminal
    • Q030399Instruments for ENT Surgery, Single-Use - OtherMDR 2 classes · n=142MDD 2 classes · n=59terminal

      Registered in EUDAMED under MDR with this code, the 142 devices are split across classes (as of 8 Sep 2026).

      • 105 Class IIa (73.9%)
      • 37 Class I (26.0%)

      Registered in EUDAMED under MDD with this code, the 59 devices are split across classes (as of 8 Sep 2026).

      • 50 Class IIa (84.7%)
      • 9 Class I (15.2%)

      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.

  • Q0304Otology Devices
    • Q030401Ear Drainage and Ventilation Devices
      • Q03040101Ear Drainage and Ventilation Catheters and CannulasMDR 2 classes · n=21MDD 2 classes · n=48terminal

        Registered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).

        • 12 Class IIa (57.1%)
        • 9 Class I (42.8%)

        Registered in EUDAMED under MDD with this code, the 48 devices are split across classes (as of 8 Sep 2026).

        • 34 Class IIb (70.8%)
        • 14 Class I (29.1%)

        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.

      • Q03040102Endolymphatic Shuntsterminal
      • Q03040199Ear Drainage and Ventilation Devices - OtherMDR 100.0% Class I · n=28MDD 2 classes · n=160terminal

        Registered in EUDAMED under MDR with this code: 28 of 28 devices carry Class I on their registration (as of 8 Sep 2026).

        • 28 Class I (100.0%)

        Registered in EUDAMED under MDD with this code, the 160 devices are split across classes (as of 8 Sep 2026).

        • 139 Class IIb (86.8%)
        • 21 Class I (13.1%)

        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.

    • Q030402Ear Irrigation Devices
      • Q03040201Ear DroppersMDD 2 classes · n=20terminal

        Registered in EUDAMED under MDD with this code, the 20 devices are split across classes (as of 8 Sep 2026).

        • 12 Class IIa (60.0%)
        • 8 Class I (40.0%)

        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.

      • Q03040299Ear Irrigation Devices - OtherMDR 2 classes · n=232MDD 95.3% Class I · n=65terminal

        Registered in EUDAMED under MDR with this code, the 232 devices are split across classes (as of 8 Sep 2026).

        • 173 Class I (74.5%)
        • 59 Class IIa (25.4%)

        Registered in EUDAMED under MDD with this code: 62 of 65 devices carry Class I on their registration (as of 8 Sep 2026).

        • 62 Class I (95.3%)
        • 3 Class IIa (4.6%)

        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.

    • Q030499Otology Devices - OtherMDR 3 classes · n=513MDD 3 classes · n=207terminal

      Registered in EUDAMED under MDR with this code, the 513 devices are split across classes (as of 8 Sep 2026).

      • 292 Class IIa (56.9%)
      • 204 Class I (39.7%)
      • 17 Class IIb (3.3%)

      Registered in EUDAMED under MDD with this code, the 207 devices are split across classes (as of 8 Sep 2026).

      • 131 Class IIa (63.2%)
      • 75 Class I (36.2%)
      • 1 Class IIb (0.4%)

      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.

  • Q0399ENT Devices - OtherMDR 4 classes · n=888MDD 4 classes · n=832terminal

    Registered in EUDAMED under MDR with this code, the 888 devices are split across classes (as of 8 Sep 2026).

    • 608 Class I (68.4%)
    • 188 Class IIa (21.1%)
    • 80 Class IIb (9.0%)
    • 12 Class III (1.3%)

    Registered in EUDAMED under MDD with this code, the 832 devices are split across classes (as of 8 Sep 2026).

    • 582 Class IIa (69.9%)
    • 243 Class I (29.2%)
    • 6 Class IIb (0.7%)
    • 1 Class III (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.