EMDN B02: Blood Filters

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.

• B02Blood Filters
  • B0201Leukoreduction Filters
    • B020101Bed-Side Leukoreduction Filters
      • B02010101Bed-Side Erythrocytes (Rbc) Leukoreduction Filters (with or without Infusion Controller)MDR 100.0% Class IIb · n=23terminal

        Registered in EUDAMED under MDR with this code: 23 of 23 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 23 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.

      • B02010102Bed-Side Platelets Leukoreduction Filters (with or without Infusion Controller)terminal
      • B02010199Bed-Side Leukoreduction Filters - Otherterminal
    • B020102Laboratory Leukoreduction Filters
      • B02010201Laboratory Erythrocytes (Rbc) Leukoreduction FiltersMDR 100.0% Class IIb · n=41terminal

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

        • 41 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.

      • B02010202Laboratory Platelets Leukoreduction Filtersterminal
      • B02010299Laboratory Leukoreduction Filters - Otherterminal
  • B0202Massive Transfusion Therapy Filters (for 40 Micron Microaggregates)
    • B020201Massive Transfusion Therapy Filters, with Transfusion Controllerterminal
    • B020202Massive Transfusion Therapy Filters, W/O Transfusion Controllerterminal
  • B0280Blood Filters - AccessoriesMDR 3 classes · n=74terminal

    Registered in EUDAMED under MDR with this code, the 74 devices are split across classes (as of 8 Sep 2026).

    • 64 Class IIa (86.4%)
    • 8 Class IIb (10.8%)
    • 2 Class I (2.7%)

    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.

  • B0299Blood Filters - Otherterminal