EMDN A11: Sample Collection Swabs

Complete hierarchy for EMDN group A11 in category A (Devices for Administration, Withdrawal and Collection): 2 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.

  • A11Sample Collection Swabs
    • A1101Sample Collection Neutral SwabsMDR 97.9% Class I · n=1,829MDD 2 classes · n=139terminal

      Registered in EUDAMED under MDR with this code: 1,792 of 1,829 devices carry Class I on their registration (as of 8 Sep 2026).

      • 1,792 Class I (97.9%)
      • 37 Class IIa (2.0%)

      Registered in EUDAMED under MDD with this code, the 139 devices are split across classes (as of 8 Sep 2026).

      • 94 Class I (67.6%)
      • 45 Class IIa (32.3%)

      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.

    • A1102Sample Collection Swabs with Transport MediumMDR 2 classes · n=143MDD 2 classes · n=128IVDR 100.0% Class A · n=271IVDD 100.0% IVD general · n=49terminal

      Registered in EUDAMED under MDR with this code, the 143 devices are split across classes (as of 8 Sep 2026).

      • 114 Class I (79.7%)
      • 29 Class IIa (20.2%)

      Registered in EUDAMED under MDD with this code, the 128 devices are split across classes (as of 8 Sep 2026).

      • 73 Class I (57.0%)
      • 55 Class IIa (42.9%)

      Registered in EUDAMED under IVDR with this code: 271 of 271 devices carry Class A on their registration (as of 8 Sep 2026).

      • 271 Class A (100.0%)

      Registered in EUDAMED under IVDD with this code: 49 of 49 devices carry IVD general on their registration (as of 8 Sep 2026).

      • 49 IVD general (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 A11 is structured

2
terminal codes, selectable in a device record
0
branch headings, not selectable
2
name a specific device type
0%
fallback entries: Other and Accessories

The Sample Collection Swabs branch runs 1 level deep. Every code below is terminal.

Frequently asked questions

Which A11 codes can be used in a EUDAMED device record?
All 2 codes listed under A11 (Sample Collection Swabs) are terminal, so any of them can be selected in a device record.
How deep is the A11 hierarchy?
The A11 branch runs 1 level below the group code.

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.

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Other groups in category A

A01NeedlesA02SyringesA03Tubular DevicesA04Solution FiltersA05Mechanical Infusion Systems, Single-UseA06Drainage and Fluids Collection DevicesA07Adapters, Connectors, Ramps, Stopcocks, CapsA08Nutrition and Infusion Bags and Containers, Single-UseA09Organ Preservation Solutions and ContainersA10Abdominal Ostomy DevicesA12Sample 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.