EMDN B03: Apheresis Devices

Complete hierarchy for EMDN group B03 in category B (Haematology and Haemotransfusion Devices): 12 terminal codes, EMDN v2026. Terminal codes are the ones accepted in a EUDAMED device record.

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.

  • B03Apheresis Devices
    • B0301Apheresis Collection Devices
      • B030101Apheresis Plasma Collection DevicesMDR 3 classes · n=99MDD 2 classes · n=35terminal

        Registered in EUDAMED under MDR with this code, the 99 devices are split across classes (as of 8 Sep 2026).

        • 80 Class IIa (80.8%)
        • 17 Class IIb (17.1%)
        • 2 Class I (2.0%)

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

        • 31 Class IIa (88.5%)
        • 4 Class IIb (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • B030102Apheresis Platelet Collection Devicesterminal
      • B030103Apheresis Leukocyte Collection Devicesterminal
      • B030104Apheresis Multiple Blood Component Collection Devicesterminal
      • B030199Apheresis Collection Devices - OtherMDR 3 classes · n=20MDD 2 classes · n=29terminal

        Registered in EUDAMED under MDR with this code, the 20 devices are split across classes (as of 8 Sep 2026).

        • 9 Class IIa (45.0%)
        • 8 Class I (40.0%)
        • 3 Class IIb (15.0%)

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

        • 18 Class IIa (62.0%)
        • 11 Class IIb (37.9%)

        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.

    • B0302Apheresis Therapy Devices
      • B030201Plasmapheresis Devices and KitsMDR 2 classes · n=89MDD 2 classes · n=171terminal

        Registered in EUDAMED under MDR with this code, the 89 devices are split across classes (as of 8 Sep 2026).

        • 62 Class IIb (69.6%)
        • 27 Class IIa (30.3%)

        Registered in EUDAMED under MDD with this code, the 171 devices are split across classes (as of 8 Sep 2026).

        • 161 Class IIb (94.1%)
        • 10 Class IIa (5.8%)

        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.

      • B030202Cytapheresis Devices and Kitsterminal
      • B030203Single Plasma Components Removal Devices and KitsMDR 2 classes · n=26terminal

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

        • 20 Class IIb (76.9%)
        • 6 Class IIa (23.0%)

        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.

      • B030204Extracorporeal Photochemotherapy or Photopheresis Devices and Kitsterminal
      • B030299Apheresis Therapy Devices - Otherterminal
    • B0380Apheresis Devices - AccessoriesMDR 3 classes · n=113terminal

      Registered in EUDAMED under MDR with this code, the 113 devices are split across classes (as of 8 Sep 2026).

      • 94 Class III (83.1%)
      • 12 Class IIa (10.6%)
      • 7 Class I (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.

    • B0399Apheresis Devices - Otherterminal

How B03 is structured

12
terminal codes, selectable in a device record
2
branch headings, not selectable
8
name a specific device type
33%
fallback entries: Other and Accessories

The Apheresis Devices branch runs 2 levels deep. 2 entries below are branch headings that group other codes rather than naming a device, so a classification has to resolve all the way down to one of the 12 codes marked terminal.

3 terminal codes are “- Other” entries and 1 is an “- Accessories” entry, 33% of the branch. An “- Other” code is the residual slot for devices its siblings do not name, so it is worth ruling out every specific sibling before settling on one.

The largest sub-branch is B0301 (Apheresis Collection Devices), holding 5 of the 12 terminal codes.

Frequently asked questions

Which B03 codes can be used in a EUDAMED device record?
12 of the 14 codes listed under B03 (Apheresis Devices) are terminal and can be selected. The other 2 are branch headings that cannot.
How deep is the B03 hierarchy?
The B03 branch runs 2 levels below the group code. Its largest sub-branch is B0301 (Apheresis Collection Devices), which holds 5 of the 12 terminal codes.
How many B03 codes are catch-all entries?
3 terminal codes under B03 are "- Other" entries and 1 is an "- Accessories" entry, 33% of the branch. The remaining 8 name a specific device type.

Not sure which level to stop at, or which of two plausible codes to submit? The guide to choosing an EMDN code walks the decision level by level, with a worked example and the mistakes that get a EUDAMED registration rejected.

Classifying more than a handful of devices?

EUDAMate maps your device list against all 6,773 terminal EMDN codes with confidence-scored suggestions you review and confirm. Start with a free Readiness Check on your own data.

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Other groups in category B

B01Blood Bags and KitsB02Blood FiltersB04Autotransfusion DevicesB05Topical Use Blood Components Preparation DevicesB06Cellular or Biological Manipulation DevicesB07Blood and Blood Components Preservation SolutionsB99Haematology and Haemotransfusion Devices - Other

Source: European Commission, EMDN v2026 official release. Terminal codes are the only codes accepted in a EUDAMED device record. EMDN is a nomenclature, not a risk classification. MDR/IVDR class is determined separately.