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.

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.

B03Apheresis Devices
- B0301Apheresis Collection Devices
  - B030101Apheresis Plasma Collection Devicesterminal
  - B030102Apheresis Platelet Collection Devicesterminal
  - B030103Apheresis Leukocyte Collection Devicesterminal
  - B030104Apheresis Multiple Blood Component Collection Devicesterminal
  - B030199Apheresis Collection Devices - Otherterminal
- B0302Apheresis Therapy Devices
  - B030201Plasmapheresis Devices and Kitsterminal
  - B030202Cytapheresis Devices and Kitsterminal
  - B030203Single Plasma Components Removal Devices and Kitsterminal
  - B030204Extracorporeal Photochemotherapy or Photopheresis Devices and Kitsterminal
  - B030299Apheresis Therapy Devices - Otherterminal
- B0380Apheresis Devices - Accessoriesterminal
- B0399Apheresis Devices - Otherterminal

How B03 is structured

terminal codes, selectable in a device record

branch headings, not selectable

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.

Classifying more than a handful of devices?

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Other groups in category B

B01Blood Bags and Kits B02Blood Filters B04Autotransfusion Devices B05Topical Use Blood Components Preparation Devices B06Cellular or Biological Manipulation Devices B07Blood and Blood Components Preservation Solutions B99Haematology 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.