EMDN A05: Mechanical Infusion Systems, Single-Use

Complete hierarchy for EMDN group A05 in category A (Devices for Administration, Withdrawal and Collection): 7 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.

  • A05Mechanical Infusion Systems, Single-Use
    • A0501Elastomeric Systems
      • A050101Elastomeric Systems - Fixed Flow
        • A05010101Elastomeric Systems - Fixed Flow W/O Additional BolusMDR 2 classes · n=1,883MDD 100.0% Class IIb · n=1,214terminal

          Registered in EUDAMED under MDR with this code, the 1,883 devices are split across classes (as of 8 Sep 2026).

          • 1,489 Class IIa (79.0%)
          • 394 Class IIb (20.9%)

          Registered in EUDAMED under MDD with this code: 1,214 of 1,214 devices carry Class IIb on their registration (as of 8 Sep 2026).

          • 1,214 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.

        • A05010102Elastomeric Systems - Fixed Flow with Additional BolusMDR 100.0% Class IIa · n=342MDD 100.0% Class IIb · n=2,579terminal

          Registered in EUDAMED under MDR with this code: 342 of 342 devices carry Class IIa on their registration (as of 8 Sep 2026).

          • 342 Class IIa (100.0%)

          Registered in EUDAMED under MDD with this code: 2,579 of 2,579 devices carry Class IIb on their registration (as of 8 Sep 2026).

          • 2,579 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.

      • A050102Elastomeric Systems - Variable Flow
        • A05010201Elastomeric Systems - Variable Flow W/O Additional BolusMDR 100.0% Class IIa · n=435MDD 2 classes · n=328terminal

          Registered in EUDAMED under MDR with this code: 435 of 435 devices carry Class IIa on their registration (as of 8 Sep 2026).

          • 435 Class IIa (100.0%)

          Registered in EUDAMED under MDD with this code, the 328 devices are split across classes (as of 8 Sep 2026).

          • 239 Class IIb (72.8%)
          • 89 Class I (27.1%)

          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.

        • A05010202Elastomeric Systems - Variable Flow with Additional BolusMDR 100.0% Class IIa · n=332MDD 100.0% Class IIb · n=2,882terminal

          Registered in EUDAMED under MDR with this code: 332 of 332 devices carry Class IIa on their registration (as of 8 Sep 2026).

          • 332 Class IIa (100.0%)

          Registered in EUDAMED under MDD with this code: 2,882 of 2,882 devices carry Class IIb on their registration (as of 8 Sep 2026).

          • 2,882 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.

    • A0502Non-Elastomeric SystemsMDD 100.0% Class IIb · n=21terminal

      Registered in EUDAMED under MDD with this code: 21 of 21 devices carry Class IIb on their registration (as of 8 Sep 2026).

      • 21 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.

    • A0580Mechanical Infusion Systems, Single-Use - Accessoriesterminal
    • A0599Mechanical Infusion Systems, Single-Use - Otherterminal

How A05 is structured

7
terminal codes, selectable in a device record
3
branch headings, not selectable
5
name a specific device type
29%
fallback entries: Other and Accessories

The Mechanical Infusion Systems, Single-Use branch runs 3 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 7 codes marked terminal.

1 terminal code is an “- Other” entry and 1 is an “- Accessories” entry, 29% 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 A05 codes can be used in a EUDAMED device record?
7 of the 10 codes listed under A05 (Mechanical Infusion Systems, Single-Use) are terminal and can be selected. The other 3 are branch headings that cannot.
How deep is the A05 hierarchy?
The A05 branch runs 3 levels below the group code.
How many A05 codes are catch-all entries?
1 terminal code under A05 is an "- Other" entry and 1 is an "- Accessories" entry, 29% of the branch. The remaining 5 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 A

A01NeedlesA02SyringesA03Tubular DevicesA04Solution FiltersA06Drainage and Fluids Collection DevicesA07Adapters, Connectors, Ramps, Stopcocks, CapsA08Nutrition and Infusion Bags and Containers, Single-UseA09Organ Preservation Solutions and ContainersA10Abdominal Ostomy DevicesA11Sample Collection SwabsA12Sample Collection SpatulasA13Applicators for Drugs and Medical Devices not Present in Other ClassesA99Devices for Administration, Withdrawal and Collection - 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.