Which B04 codes can be used in a EUDAMED device record?

All 4 codes listed under B04 (Autotransfusion Devices) are terminal, so any of them can be selected in a device record.

How deep is the B04 hierarchy?

The B04 branch runs 1 level below the group code.

How many B04 codes are catch-all entries?

1 terminal code under B04 is an "- Other" entry and 1 is an "- Accessories" entry, 50% of the branch. The remaining 2 name a specific device type.

EMDN B04: Autotransfusion Devices

Complete hierarchy for EMDN group B04 in category B (Haematology and Haemotransfusion Devices): 4 terminal codes, EMDN v2026. Terminal codes are the ones accepted in a EUDAMED device record.

B04Autotransfusion Devices
- B0401Intra- and Postoperative Blood Collection, Washing and Reinfusion Devices and Kitsterminal
- B0402Intra- and Postoperative Blood Collection and Reinfusion Only Devices and Kitsterminal
- B0480Autotransfusion Devices - Accessoriesterminal
- B0499Autotransfusion Devices - Otherterminal

How B04 is structured

terminal codes, selectable in a device record

branch headings, not selectable

name a specific device type

50%

fallback entries: Other and Accessories

The Autotransfusion Devices branch runs 1 level deep. Every code below is terminal.

1 terminal code is an “- Other” entry and 1 is an “- Accessories” entry, 50% 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.

Frequently asked questions

Which B04 codes can be used in a EUDAMED device record?: All 4 codes listed under B04 (Autotransfusion Devices) are terminal, so any of them can be selected in a device record.
How deep is the B04 hierarchy?: The B04 branch runs 1 level below the group code.
How many B04 codes are catch-all entries?: 1 terminal code under B04 is an "- Other" entry and 1 is an "- Accessories" entry, 50% of the branch. The remaining 2 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 B03Apheresis 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.