Which B02 codes can be used in a EUDAMED device record?

10 of the 14 codes listed under B02 (Blood Filters) are terminal and can be selected. The other 4 are branch headings that cannot.

How deep is the B02 hierarchy?

The B02 branch runs 3 levels below the group code. Its largest sub-branch is B0201 (Leukoreduction Filters), which holds 6 of the 10 terminal codes.

How many B02 codes are catch-all entries?

3 terminal codes under B02 are "- Other" entries and 1 is an "- Accessories" entry, 40% of the branch. The remaining 6 name a specific device type.

EMDN B02: Blood Filters

Complete hierarchy for EMDN group B02 in category B (Haematology and Haemotransfusion Devices): 10 terminal codes, EMDN v2026. Terminal codes are the ones accepted in a EUDAMED device record.

B02Blood Filters
- B0201Leukoreduction Filters
  - B020101Bed-Side Leukoreduction Filters
    - B02010101Bed-Side Erythrocytes (Rbc) Leukoreduction Filters (with or without Infusion Controller)terminal
    - B02010102Bed-Side Platelets Leukoreduction Filters (with or without Infusion Controller)terminal
    - B02010199Bed-Side Leukoreduction Filters - Otherterminal
  - B020102Laboratory Leukoreduction Filters
    - B02010201Laboratory Erythrocytes (Rbc) Leukoreduction Filtersterminal
    - 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 - Accessoriesterminal
- B0299Blood Filters - Otherterminal

How B02 is structured

terminal codes, selectable in a device record

branch headings, not selectable

name a specific device type

40%

fallback entries: Other and Accessories

The Blood Filters branch runs 3 levels deep. 4 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 10 codes marked terminal.

3 terminal codes are “- Other” entries and 1 is an “- Accessories” entry, 40% 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 B0201 (Leukoreduction Filters), holding 6 of the 10 terminal codes.

Frequently asked questions

Which B02 codes can be used in a EUDAMED device record?: 10 of the 14 codes listed under B02 (Blood Filters) are terminal and can be selected. The other 4 are branch headings that cannot.
How deep is the B02 hierarchy?: The B02 branch runs 3 levels below the group code. Its largest sub-branch is B0201 (Leukoreduction Filters), which holds 6 of the 10 terminal codes.
How many B02 codes are catch-all entries?: 3 terminal codes under B02 are "- Other" entries and 1 is an "- Accessories" entry, 40% of the branch. The remaining 6 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 B03Apheresis Devices 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.