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.
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.
B04Autotransfusion DevicesB0401Intra- and Postoperative Blood Collection, Washing and Reinfusion Devices and KitsMDR 100.0% Class IIb · n=35MDD 95.6% Class IIa · n=23terminalRegistered in EUDAMED under MDR with this code: 35 of 35 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 35 Class IIb (100.0%)
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 IIb (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.
B0402Intra- and Postoperative Blood Collection and Reinfusion Only Devices and KitsterminalRegistered in EUDAMED under MDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).
- 34 Class IIa (69.3%)
- 9 Class I (18.3%)
- 6 Class IIb (12.2%)
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.
Registered in EUDAMED under MDR with this code, the 68 devices are split across classes (as of 8 Sep 2026).
- 62 Class I (91.1%)
- 5 Class IIa (7.3%)
- 1 Class IIb (1.4%)
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.
How B04 is structured
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.
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.
Run a free Readiness CheckOther groups in category B
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.