EMDN F04: Dialysis Concentrates

Complete hierarchy for EMDN group F04 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.

  • F04Dialysis Concentrates
    • F0401Dialysis Concentrates, Acid Solutions
      • F040101Dialysis Concentrates, Acid Solutions, Non-SterileMDR 100.0% Class IIb · n=578MDD 100.0% Class IIb · n=379terminal

        Registered in EUDAMED under MDR with this code: 578 of 578 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 578 Class IIb (100.0%)

        Registered in EUDAMED under MDD with this code: 379 of 379 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 379 Class IIb (100.0%)

        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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • F040102Dialysis Concentrates, Acid Solutions, Sterileterminal
    • F0402Dialysis Concentrates, Basic Solutions
      • F040201Dialysis Concentrates, Basic Solutions, PowderMDR 100.0% Class IIb · n=147MDD 100.0% Class IIb · n=130terminal

        Registered in EUDAMED under MDR with this code: 147 of 147 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 147 Class IIb (100.0%)

        Registered in EUDAMED under MDD with this code: 130 of 130 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 130 Class IIb (100.0%)

        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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • F040202Dialysis Concentrates, Basic Solutions, LiquidMDD 100.0% Class IIb · n=34terminal

        Registered in EUDAMED under MDD with this code: 34 of 34 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 34 Class IIb (100.0%)

        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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • F0403Dialysis Concentrates, without Acetate Buffer
      • F040302Dialysis Concentrates, without Acetate Buffer - Afbterminal
      • F040399Dialysis Concentrates, without Acetate Buffer for Other Treatmentsterminal
    • F0404Dialysis Procedures, Saltsterminal
    • F0499Dialysis Concentrates - OtherMDD 100.0% Class IIb · n=637terminal

      Registered in EUDAMED under MDD with this code: 637 of 637 devices carry Class IIb on their registration (as of 8 Sep 2026).

      • 637 Class IIb (100.0%)

      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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

How F04 is structured

8
terminal codes, selectable in a device record
3
branch headings, not selectable
6
name a specific device type
25%
fallback entries: Other and Accessories

The Dialysis Concentrates branch runs 2 levels deep. 3 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 8 codes marked terminal.

2 terminal codes are “- Other” entries, 25% 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 F0401 (Dialysis Concentrates, Acid Solutions), holding 2 of the 8 terminal codes.

Frequently asked questions

Which F04 codes can be used in a EUDAMED device record?
8 of the 11 codes listed under F04 (Dialysis Concentrates) are terminal and can be selected. The other 3 are branch headings that cannot.
How deep is the F04 hierarchy?
The F04 branch runs 2 levels below the group code. Its largest sub-branch is F0401 (Dialysis Concentrates, Acid Solutions), which holds 2 of the 8 terminal codes.
How many F04 codes are catch-all entries?
2 terminal codes under F04 are "- Other" entries, 25% of the branch. The remaining 6 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 Check

Other groups in category F

F01Dialysis FiltersF02Dialysis LinesF03Dialysis KitsF05Devices for Microdialysis of Specific OrgansF90Dialysis Devices - Various

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.