EMDN F03: Dialysis Kits
Complete hierarchy for EMDN group F03 in category F (Dialysis Devices): 8 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.
F03Dialysis KitsRegistered in EUDAMED under MDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).
- 20 Class IIa (71.4%)
- 8 Class IIb (28.5%)
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.
F0302Biofiltration KitsterminalRegistered in EUDAMED under MDR with this code, the 948 devices are split across classes (as of 8 Sep 2026).
- 435 Class I (45.8%)
- 312 Class IIa (32.9%)
- 101 Class IIb (10.6%)
- 100 Class III (10.5%)
Registered in EUDAMED under MDD with this code, the 184 devices are split across classes (as of 8 Sep 2026).
- 129 Class I (70.1%)
- 54 Class IIa (29.3%)
- 1 Class III (0.5%)
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.
F0304Dialysis Washing/Filling KitsterminalF0305Haemoperfusion KitsterminalF0306Continuous Dialysis KitsterminalF0307Ultrafiltration KitsterminalRegistered in EUDAMED under MDR with this code, the 48 devices are split across classes (as of 8 Sep 2026).
- 22 Class I (45.8%)
- 17 Class IIa (35.4%)
- 8 Class III (16.6%)
- 1 Class IIb (2.0%)
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.
How F03 is structured
The Dialysis Kits branch runs 1 level deep. Every code below is terminal.
1 terminal code is an “- Other” entry, 13% 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 F03 codes can be used in a EUDAMED device record?
- All 8 codes listed under F03 (Dialysis Kits) are terminal, so any of them can be selected in a device record.
- How deep is the F03 hierarchy?
- The F03 branch runs 1 level below the group code.
- How many F03 codes are catch-all entries?
- 1 terminal code under F03 is an "- Other" entry, 13% of the branch. The remaining 7 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 F
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.