EMDN B01: Blood Bags and Kits

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.

• B01Blood Bags and Kits
  • B0101Blood Collection Bags and Kits
    • B010101Autologous Blood Collection Bags
      • B01010101Autotransfusion Bags, with Filters and Kits
        • B0101010101Autotransfusion Double Bags, with Filters and Kitsterminal
        • B0101010199Autotransfusion Bags, with Filters and Kits - Otherterminal
      • B01010102Autotransfusion Bags, W/O Filters and Kits
        • B0101010201Autotransfusion Singular Bags, W/O Filters and Kitsterminal
        • B0101010202Autotransfusion Double Bags, W/O Filters and Kitsterminal
        • B0101010203Autotransfusion Triple Bags, W/O Filters and Kitsterminal
        • B0101010299Autotransfusion Bags, W/O Filters and Kits - Otherterminal
    • B010102Homologous Donor Blood Collection Bags and Kits
      • B01010201Donor Blood Collection Bags, with Filters and Kits
        • B0101020101Donor Blood Collection Quadruple Bags, with Filters and KitsMDD 2 classes · n=86terminal

          Registered in EUDAMED under MDD with this code, the 86 devices are split across classes (as of 8 Sep 2026).

          • 74 Class IIb (86.0%)
          • 12 Class III (13.9%)

          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.

        • B0101020102Donor Blood Collection Quintuple Bags, with Filters and KitsMDD 2 classes · n=32terminal

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

          • 25 Class IIb (78.1%)
          • 7 Class III (21.8%)

          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.

        • B0101020199Donor Blood Collection Bags and Kits, with Filters - Otherterminal
      • B01010202Donor Blood Collection Bags, W/O Filters and Kits - Other
        • B0101020201Donor Blood Collection Triple Bags, W/O Filters and KitMDD 2 classes · n=106terminal

          Registered in EUDAMED under MDD with this code, the 106 devices are split across classes (as of 8 Sep 2026).

          • 82 Class IIb (77.3%)
          • 24 Class III (22.6%)

          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.

        • B0101020202Donor Blood Collection Quadruple Bags, W/O Filters and KitsMDD 2 classes · n=76terminal

          Registered in EUDAMED under MDD with this code, the 76 devices are split across classes (as of 8 Sep 2026).

          • 60 Class IIb (78.9%)
          • 16 Class III (21.0%)

          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.

        • B0101020299Donor Blood Collection Bags W/O Filters and Kits - OtherMDD 2 classes · n=187terminal

          Registered in EUDAMED under MDD with this code, the 187 devices are split across classes (as of 8 Sep 2026).

          • 160 Class IIb (85.5%)
          • 27 Class III (14.4%)

          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.

    • B010199Blood Collection Bags and Kits - OtherMDR 3 classes · n=29MDD 2 classes · n=55terminal

      Registered in EUDAMED under MDR with this code, the 29 devices are split across classes (as of 8 Sep 2026).

      • 15 Class I (51.7%)
      • 8 Class III (27.5%)
      • 6 Class IIa (20.6%)

      Registered in EUDAMED under MDD with this code, the 55 devices are split across classes (as of 8 Sep 2026).

      • 41 Class IIb (74.5%)
      • 14 Class IIa (25.4%)

      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.

  • B0102Blood Transfer Bags and Kits
    • B010201Whole Blood, Red Blood Cells or Plasma Transfer Bags and KitsMDR 2 classes · n=29MDD 2 classes · n=68terminal

      Registered in EUDAMED under MDR with this code, the 29 devices are split across classes (as of 8 Sep 2026).

      • 16 Class IIb (55.1%)
      • 13 Class IIa (44.8%)

      Registered in EUDAMED under MDD with this code, the 68 devices are split across classes (as of 8 Sep 2026).

      • 46 Class IIb (67.6%)
      • 22 Class IIa (32.3%)

      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.

    • B010202Platelets Concentrate Transfer Bags and KitsMDR 3 classes · n=45MDD 2 classes · n=64terminal

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

      • 27 Class III (60.0%)
      • 11 Class IIb (24.4%)
      • 7 Class IIa (15.5%)

      Registered in EUDAMED under MDD with this code, the 64 devices are split across classes (as of 8 Sep 2026).

      • 44 Class IIb (68.7%)
      • 20 Class IIa (31.2%)

      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.

    • B010299Blood Transfer Bags and Kits - OtherMDD 2 classes · n=44terminal

      Registered in EUDAMED under MDD with this code, the 44 devices are split across classes (as of 8 Sep 2026).

      • 25 Class IIb (56.8%)
      • 19 Class IIa (43.1%)

      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.

  • B0103Medullary Blood Collection, Purification, Cryopreservation Bags and KitsMDD 2 classes · n=46terminal

    Registered in EUDAMED under MDD with this code, the 46 devices are split across classes (as of 8 Sep 2026).

    • 43 Class IIa (93.4%)
    • 3 Class IIb (6.5%)

    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.

  • B0104Placental Blood Bags and Kits
    • B010401Placental Blood Collection Bags and Kitsterminal
    • B010402Placental Blood Purification Bags and Kitsterminal
    • B010403Placental Blood Cryopreservation Bags and Kitsterminal
    • B010499Placental Blood Bags and Kits - Otherterminal
  • B0105Umbilical Cord Blood Collection, Purification, Cryopreservation Bags and Kitsterminal
  • B0180Blood Bags and Kits - AccessoriesMDR 2 classes · n=76MDD 95.6% Class IIa · n=23terminal

    Registered in EUDAMED under MDR with this code, the 76 devices are split across classes (as of 8 Sep 2026).

    • 69 Class I (90.7%)
    • 7 Class IIa (9.2%)

    Registered in EUDAMED under MDD with this code: 22 of 23 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 22 Class IIa (95.6%)
    • 1 Class I (4.3%)

    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.

  • B0190Blood Bags and Kits - Various
    • B019001Platelet Gel and Fibrin Glue Production Bags and Kitsterminal
    • B019002Collection and Filtration of Whole Blood with Aliquotation of Concentrated Red Blood Cells Bags and Kitsterminal
    • B019003Blood Components Aliquotation Kitsterminal
    • B019004Blood Components Sampling Bags and Kitsterminal
  • B0199Blood Bags and Kits - Otherterminal