EMDN C04: Cardiovascular Guidewires

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.

• C04Cardiovascular Guidewires
  • C0401Coronary Artery Guidewires
    • C040101Coronary Artery Diagnostic Guidewires
      • C04010101Coronary Artery Diagnostic Guidewires, HydrophilicMDD 3 classes · n=267terminal

        Registered in EUDAMED under MDD with this code, the 267 devices are split across classes (as of 8 Sep 2026).

        • 253 Class III (94.7%)
        • 11 Class IIa (4.1%)
        • 3 Class IIb (1.1%)

        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.

      • C04010102Coronary Artery Diagnostic Guidewires, Non-HydrophilicMDD 100.0% Class IIa · n=30terminal

        Registered in EUDAMED under MDD with this code: 30 of 30 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 30 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.

      • C04010199Coronary Artery Diagnostic Guidewires - Otherterminal
    • C040102Coronary Artery Therapeutic Guidewires
      • C04010201Coronary Artery Therapeutic Guidewires, HydrophilicMDR 3 classes · n=135terminal

        Registered in EUDAMED under MDR with this code, the 135 devices are split across classes (as of 8 Sep 2026).

        • 125 Class III (92.5%)
        • 9 Class IIa (6.6%)
        • 1 Class I (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.

      • C04010202Coronary Artery Therapeutic Guidewires, Non-HydrophilicMDR 2 classes · n=49terminal

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

        • 46 Class III (93.8%)
        • 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.

      • C04010299Coronary Artery Therapeutic Guidewires - Otherterminal
  • C0402Peripheral Vascular Guidewires
    • C040201Peripheral Vascular Diagnostic Guidewires
      • C04020101Peripheral Vascular Diagnostic Guidewires, HydrophilicMDR 100.0% Class IIa · n=528MDD 3 classes · n=281terminal

        Registered in EUDAMED under MDR with this code: 528 of 528 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 528 Class IIa (100.0%)

        Registered in EUDAMED under MDD with this code, the 281 devices are split across classes (as of 8 Sep 2026).

        • 182 Class III (64.7%)
        • 98 Class IIa (34.8%)
        • 1 Class IIb (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • C04020102Peripheral Vascular Diagnostic Guidewires, Non-HydrophilicMDR 2 classes · n=199MDD 3 classes · n=169terminal

        Registered in EUDAMED under MDR with this code, the 199 devices are split across classes (as of 8 Sep 2026).

        • 118 Class IIa (59.2%)
        • 81 Class III (40.7%)

        Registered in EUDAMED under MDD with this code, the 169 devices are split across classes (as of 8 Sep 2026).

        • 121 Class IIa (71.5%)
        • 47 Class III (27.8%)
        • 1 Class I (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.

      • C04020199Peripheral Vascular Diagnostic Guidewires- OtherMDR 100.0% Class IIa · n=36terminal

        Registered in EUDAMED under MDR with this code: 36 of 36 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 36 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.

    • C040202Peripheral Vascular Therapeutic Guidewires
      • C04020201Peripheral Vascular Therapeutic Guidewires, HydrophilicMDR 100.0% Class IIa · n=250MDD 2 classes · n=90terminal

        Registered in EUDAMED under MDR with this code: 250 of 250 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 250 Class IIa (100.0%)

        Registered in EUDAMED under MDD with this code, the 90 devices are split across classes (as of 8 Sep 2026).

        • 71 Class IIa (78.8%)
        • 19 Class III (21.1%)

        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.

      • C04020202Peripheral Vascular Therapeutic Guidewires, Non-HydrophilicMDR 100.0% Class IIa · n=187MDD 100.0% Class IIa · n=35terminal

        Registered in EUDAMED under MDR with this code: 187 of 187 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 187 Class IIa (100.0%)

        Registered in EUDAMED under MDD with this code: 35 of 35 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 35 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.

      • C04020299Peripheral Vascular Guidewires, Therapeutical - OtherMDR 98.0% Class IIa · n=51MDD 100.0% Class IIa · n=25terminal

        Registered in EUDAMED under MDR with this code: 50 of 51 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 50 Class IIa (98.0%)
        • 1 Class III (1.9%)

        Registered in EUDAMED under MDD with this code: 25 of 25 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 25 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.

  • C0403Coronary and Peripheral Vascular Guide Wires
    • C040301Diagnostic Coronary and Peripheral Vascular Guide Wires
      • C04030101Diagnostic Coronary and Peripheral Vascular Guide Wires, HydrophilicMDR 100.0% Class III · n=78MDD 2 classes · n=382terminal

        Registered in EUDAMED under MDR with this code: 78 of 78 devices carry Class III on their registration (as of 8 Sep 2026).

        • 78 Class III (100.0%)

        Registered in EUDAMED under MDD with this code, the 382 devices are split across classes (as of 8 Sep 2026).

        • 270 Class IIa (70.6%)
        • 112 Class III (29.3%)

        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.

      • C04030102Diagnostic Coronary and Peripheral Vascular Guide Wires, Non-HydrophilicMDR 100.0% Class III · n=120MDD 100.0% Class IIa · n=115terminal

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

        • 120 Class III (100.0%)

        Registered in EUDAMED under MDD with this code: 115 of 115 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 115 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.

      • C04030199Diagnostic Coronary and Peripheral Vascular Guide Wires - Otherterminal
    • C040302Interventional Coronary and Peripheral Vascular Guide Wires
      • C04030201Interventional Coronary and Peripheral Vascular Guide Wires, HydrophilicMDR 2 classes · n=45MDD 99.1% Class III · n=229terminal

        Registered in EUDAMED under MDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).

        • 33 Class III (73.3%)
        • 12 Class IIa (26.6%)

        Registered in EUDAMED under MDD with this code: 227 of 229 devices carry Class III on their registration (as of 8 Sep 2026).

        • 227 Class III (99.1%)
        • 1 Class IIa (0.4%)
        • 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.

      • C04030202Interventional Coronary and Peripheral Vascular Guide Wires, Non-Hydrophilicterminal
      • C04030299Interventional Coronary and Peripheral Vascular Guide Wires - Otherterminal
  • C0404Neurovascular Guidewires
    • C040401Neurovascular Diagnostic Guidewires
      • C04040101Neurovascular Diagnostic Guidewires, Hydrophilicterminal
      • C04040102Neurovascular Diagnostic Guidewires, Non-Hydrophilicterminal
      • C04040199Neurovascular Diagnostic Guidewires - Otherterminal
    • C040402Neurovascular Therapeutic Guidewires
      • C04040201Neurovascular Therapeutic Guidewires, Hydrophilicterminal
      • C04040202Neurovascular Therapeutic Guidewires, Non-Hydrophilicterminal
      • C04040299Neurovascular Therapeutic Guidewires - Otherterminal
  • C0480Cardiovascular Guidewires - AccessoriesMDR 100.0% Class I · n=68terminal

    Registered in EUDAMED under MDR with this code: 68 of 68 devices carry Class I on their registration (as of 8 Sep 2026).

    • 68 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.

  • C0499Cardiovascular Guidewires - OtherMDR 2 classes · n=50MDD 3 classes · n=193terminal

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

    • 34 Class III (68.0%)
    • 16 Class I (32.0%)

    Registered in EUDAMED under MDD with this code, the 193 devices are split across classes (as of 8 Sep 2026).

    • 150 Class IIa (77.7%)
    • 41 Class III (21.2%)
    • 2 Class IIb (1.0%)

    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.