EMDN A03: Tubular 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.

• A03Tubular Devices
  • A0301Flow Controllers
    • A030101Infusion Controllers
      • A03010101Infusion Controllers with or W/O Air InletMDR 3 classes · n=1,140MDD 2 classes · n=184terminal

        Registered in EUDAMED under MDR with this code, the 1,140 devices are split across classes (as of 8 Sep 2026).

        • 870 Class IIa (76.3%)
        • 269 Class I (23.5%)
        • 1 Class IIb (<0.1%)

        Registered in EUDAMED under MDD with this code, the 184 devices are split across classes (as of 8 Sep 2026).

        • 119 Class I (64.6%)
        • 65 Class IIa (35.3%)

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

      • A03010102Infusion Controllers with Filter (Also Transfusion Controllers)MDR 96.0% Class IIa · n=407MDD 2 classes · n=66terminal

        Registered in EUDAMED under MDR with this code: 391 of 407 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 391 Class IIa (96.0%)
        • 16 Class I (3.9%)

        Registered in EUDAMED under MDD with this code, the 66 devices are split across classes (as of 8 Sep 2026).

        • 61 Class IIa (92.4%)
        • 5 Class I (7.5%)

        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.

      • A03010103Infusion Controllers with Flow RegulatorMDR 3 classes · n=726MDD 2 classes · n=67terminal

        Registered in EUDAMED under MDR with this code, the 726 devices are split across classes (as of 8 Sep 2026).

        • 625 Class IIa (86.0%)
        • 97 Class I (13.3%)
        • 4 Class IIb (0.5%)

        Registered in EUDAMED under MDD with this code, the 67 devices are split across classes (as of 8 Sep 2026).

        • 34 Class I (50.7%)
        • 33 Class IIa (49.2%)

        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.

      • A03010104Infusion Micro-ControllersMDR 100.0% Class IIa · n=84MDD 2 classes · n=28terminal

        Registered in EUDAMED under MDR with this code: 84 of 84 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 84 Class IIa (100.0%)

        Registered in EUDAMED under MDD with this code, the 28 devices are split across classes (as of 8 Sep 2026).

        • 25 Class I (89.2%)
        • 3 Class IIa (10.7%)

        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.

      • A03010105Infusion Pump ControllersMDR 100.0% Class IIa · n=654MDD 96.3% Class IIa · n=55terminal

        Registered in EUDAMED under MDR with this code: 654 of 654 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 654 Class IIa (100.0%)

        Registered in EUDAMED under MDD with this code: 53 of 55 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 53 Class IIa (96.3%)
        • 2 Class IIb (3.6%)

        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.

      • A03010199Infusion Controllers - OtherMDR 3 classes · n=176MDD 2 classes · n=60terminal

        Registered in EUDAMED under MDR with this code, the 176 devices are split across classes (as of 8 Sep 2026).

        • 106 Class IIa (60.2%)
        • 56 Class I (31.8%)
        • 14 Class IIb (7.9%)

        Registered in EUDAMED under MDD with this code, the 60 devices are split across classes (as of 8 Sep 2026).

        • 37 Class I (61.6%)
        • 23 Class IIa (38.3%)

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

    • A030102Irrigation Controllers
      • A03010201Arthroscopic Irrigation Controllersterminal
      • A03010202Urological Irrigation ControllersMDR 2 classes · n=39MDD 2 classes · n=31terminal

        Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).

        • 31 Class IIa (79.4%)
        • 8 Class I (20.5%)

        Registered in EUDAMED under MDD with this code, the 31 devices are split across classes (as of 8 Sep 2026).

        • 20 Class I (64.5%)
        • 11 Class IIa (35.4%)

        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.

      • A03010299Irrigation Controllers - OtherMDR 3 classes · n=166terminal

        Registered in EUDAMED under MDR with this code, the 166 devices are split across classes (as of 8 Sep 2026).

        • 120 Class IIa (72.2%)
        • 44 Class I (26.5%)
        • 2 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.

    • A030103Enteral Feeding Controllers
      • A03010301Enteral Feeding Gravity ControllersMDR 2 classes · n=26terminal

        Registered in EUDAMED under MDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).

        • 21 Class I (80.7%)
        • 5 Class IIa (19.2%)

        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.

      • A03010302Enteral Feeding Pump Controllersterminal
      • A03010399Enteral Feeding Controllers - Otherterminal
    • A030104Flow RegulatorsMDR 3 classes · n=155MDD 3 classes · n=413terminal

      Registered in EUDAMED under MDR with this code, the 155 devices are split across classes (as of 8 Sep 2026).

      • 87 Class IIa (56.1%)
      • 57 Class I (36.7%)
      • 11 Class IIb (7.0%)

      Registered in EUDAMED under MDD with this code, the 413 devices are split across classes (as of 8 Sep 2026).

      • 335 Class IIb (81.1%)
      • 73 Class IIa (17.6%)
      • 5 Class I (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.

    • A030105Fluids Heating SystemsMDR 98.6% Class I · n=152MDD 2 classes · n=23terminal

      Registered in EUDAMED under MDR with this code: 150 of 152 devices carry Class I on their registration (as of 8 Sep 2026).

      • 150 Class I (98.6%)
      • 2 Class IIb (1.3%)

      Registered in EUDAMED under MDD with this code, the 23 devices are split across classes (as of 8 Sep 2026).

      • 21 Class IIb (91.3%)
      • 2 Class I (8.6%)

      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.

    • A030199Controllers - OtherMDR 3 classes · n=49terminal

      Registered in EUDAMED under MDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).

      • 39 Class I (79.5%)
      • 7 Class IIb (14.2%)
      • 3 Class IIa (6.1%)

      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.

  • A0302Extension Lines
    • A030201Extensions
      • A03020101Low Pressure Extension LinesMDR 2 classes · n=3,429MDD 2 classes · n=804terminal

        Registered in EUDAMED under MDR with this code, the 3,429 devices are split across classes (as of 8 Sep 2026).

        • 3,151 Class IIa (91.8%)
        • 278 Class I (8.1%)

        Registered in EUDAMED under MDD with this code, the 804 devices are split across classes (as of 8 Sep 2026).

        • 537 Class IIa (66.7%)
        • 267 Class I (33.2%)

        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.

      • A03020102High Pressure Extension LinesMDR 2 classes · n=1,730MDD 2 classes · n=362terminal

        Registered in EUDAMED under MDR with this code, the 1,730 devices are split across classes (as of 8 Sep 2026).

        • 1,593 Class IIa (92.0%)
        • 137 Class I (7.9%)

        Registered in EUDAMED under MDD with this code, the 362 devices are split across classes (as of 8 Sep 2026).

        • 294 Class IIa (81.2%)
        • 68 Class I (18.7%)

        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.

      • A03020199Extensions - OtherMDR 2 classes · n=1,621MDD 2 classes · n=260terminal

        Registered in EUDAMED under MDR with this code, the 1,621 devices are split across classes (as of 8 Sep 2026).

        • 1,294 Class IIa (79.8%)
        • 327 Class I (20.1%)

        Registered in EUDAMED under MDD with this code, the 260 devices are split across classes (as of 8 Sep 2026).

        • 160 Class IIa (61.5%)
        • 100 Class I (38.4%)

        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.

  • A0303Rapid Infusion Systems (High Flow)terminal
  • A0304Administration Kits
    • A030401Infusion Kits (Including Those Via Pump), Single-Use
      • A03040101Kits for Continuous Subcutaneous Insulin InfusionMDR 100.0% Class IIb · n=31terminal

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

        • 31 Class IIb (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.

      • A03040102Intraosseous Infusion Kits, Single-Useterminal
      • A03040199Infusion Kits (with or W/O Pump), Single-Use - OtherMDR 4 classes · n=1,372MDD 98.1% Class IIa · n=433terminal

        Registered in EUDAMED under MDR with this code, the 1,372 devices are split across classes (as of 8 Sep 2026).

        • 1,232 Class IIa (89.7%)
        • 73 Class I (5.3%)
        • 64 Class III (4.6%)
        • 3 Class IIb (0.2%)

        Registered in EUDAMED under MDD with this code: 425 of 433 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 425 Class IIa (98.1%)
        • 6 Class IIb (1.3%)
        • 2 Class I (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.

    • A030402Irrigation Kits, Single-Use
      • A03040201Bladder Irrigation Kits, Single-UseMDR 3 classes · n=37terminal

        Registered in EUDAMED under MDR with this code, the 37 devices are split across classes (as of 8 Sep 2026).

        • 18 Class III (48.6%)
        • 17 Class I (45.9%)
        • 2 Class IIa (5.4%)

        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.

      • A03040202Ocular Irrigation Kits, Single-UseMDR 3 classes · n=35terminal

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

        • 21 Class I (60.0%)
        • 10 Class IIb (28.5%)
        • 4 Class IIa (11.4%)

        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.

      • A03040203Perineal Irrigation Kits, Single-Useterminal
      • A03040204Ear Irrigation Kits, Single-UseMDR 100.0% Class I · n=64terminal

        Registered in EUDAMED under MDR with this code: 64 of 64 devices carry Class I on their registration (as of 8 Sep 2026).

        • 64 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.

      • A03040299Irrigation Kits, Single-Use - OtherMDR 2 classes · n=315MDD 99.0% Class IIa · n=215terminal

        Registered in EUDAMED under MDR with this code, the 315 devices are split across classes (as of 8 Sep 2026).

        • 194 Class IIa (61.5%)
        • 121 Class I (38.4%)

        Registered in EUDAMED under MDD with this code: 213 of 215 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 213 Class IIa (99.0%)
        • 2 Class I (0.9%)

        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.

    • A030403Enteral Nutrition Kits (Including Those Via Pump), Single-UseMDR 3 classes · n=814MDD 2 classes · n=34terminal

      Registered in EUDAMED under MDR with this code, the 814 devices are split across classes (as of 8 Sep 2026).

      • 725 Class IIa (89.0%)
      • 70 Class I (8.5%)
      • 19 Class IIb (2.3%)

      Registered in EUDAMED under MDD with this code, the 34 devices are split across classes (as of 8 Sep 2026).

      • 21 Class I (61.7%)
      • 13 Class IIa (38.2%)

      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.

    • A030499Administration Kits - OtherMDR 4 classes · n=868MDD 2 classes · n=103terminal

      Registered in EUDAMED under MDR with this code, the 868 devices are split across classes (as of 8 Sep 2026).

      • 355 Class IIa (40.8%)
      • 264 Class I (30.4%)
      • 209 Class IIb (24.0%)
      • 40 Class III (4.6%)

      Registered in EUDAMED under MDD with this code, the 103 devices are split across classes (as of 8 Sep 2026).

      • 56 Class IIa (54.3%)
      • 47 Class I (45.6%)

      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.

  • A0380Tubular Devices - AccessoriesMDR 2 classes · n=309MDD 2 classes · n=50terminal

    Registered in EUDAMED under MDR with this code, the 309 devices are split across classes (as of 8 Sep 2026).

    • 289 Class I (93.5%)
    • 20 Class IIa (6.4%)

    Registered in EUDAMED under MDD with this code, the 50 devices are split across classes (as of 8 Sep 2026).

    • 46 Class IIa (92.0%)
    • 4 Class I (8.0%)

    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.

  • A0399Tubular Devices - OtherMDR 3 classes · n=415MDD 2 classes · n=56terminal

    Registered in EUDAMED under MDR with this code, the 415 devices are split across classes (as of 8 Sep 2026).

    • 355 Class I (85.5%)
    • 51 Class IIa (12.2%)
    • 9 Class IIb (2.1%)

    Registered in EUDAMED under MDD with this code, the 56 devices are split across classes (as of 8 Sep 2026).

    • 41 Class IIa (73.2%)
    • 15 Class I (26.7%)

    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.