EMDN F90: Dialysis Devices - Various

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.

• F90Dialysis Devices - Various
  • F9001Peritonaeal Dialysis Devices (not Included in Other Groups)
    • F900101Peritoneal Dialysis Catheters and KitsMDD 3 classes · n=32terminal

      Registered in EUDAMED under MDD with this code, the 32 devices are split across classes (as of 8 Sep 2026).

      • 24 Class IIb (75.0%)
      • 7 Class IIa (21.8%)
      • 1 Class I (3.1%)

      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.

    • F900199Peritonaeal Dialysis - Otherterminal
  • F9002Vascular Access Devices (Only for Haemodialysis)
    • F900201Temporary Hemodialysis Catheters and KitsMDR 2 classes · n=120MDD 2 classes · n=341terminal

      Registered in EUDAMED under MDR with this code, the 120 devices are split across classes (as of 8 Sep 2026).

      • 108 Class IIa (90.0%)
      • 12 Class III (10.0%)

      Registered in EUDAMED under MDD with this code, the 341 devices are split across classes (as of 8 Sep 2026).

      • 220 Class IIa (64.5%)
      • 121 Class IIb (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.

    • F900202Permanent Hemodialysis Catheters and KitsMDD 100.0% Class III · n=201terminal

      Registered in EUDAMED under MDD with this code: 201 of 201 devices carry Class III on their registration (as of 8 Sep 2026).

      • 201 Class III (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.

    • F900299Vascular Access Devices (Only for Haemodialysis) - Otherterminal
  • F9003Dialysis Adaptors
    • F900301Haemodialysis Adaptorsterminal
    • F900302Peritonaeal Dialysis Adaptorsterminal
  • F9004Dialysate Collection and Reinfusion Bags
    • F900401Dialysate Collection Bags
      • F90040101Haemodialysate Collection Bagsterminal
      • F90040102Peritonaeal Dialysate Collection Bagsterminal
    • F900402Dialysate Reinfusion Bagsterminal
  • F9006Dialytic Treatment Instruments, Single-Useterminal
  • F9080Dialysis Devices - Other AccessoriesMDR 2 classes · n=47terminal

    Registered in EUDAMED under MDR with this code, the 47 devices are split across classes (as of 8 Sep 2026).

    • 30 Class I (63.8%)
    • 17 Class IIa (36.1%)

    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.

  • F9099Dialysis Devices - OtherMDR 2 classes · n=35MDD 3 classes · n=39terminal

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

    • 24 Class IIb (68.5%)
    • 11 Class I (31.4%)

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

    • 20 Class I (51.2%)
    • 15 Class IIb (38.4%)
    • 4 Class IIa (10.2%)

    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.