EMDN U05: Urodynamics Devices

Complete hierarchy for EMDN group U05 in category U (Devices for Urogenital System): 14 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.

  • U05Urodynamics Devices
    • U0501Cystomanometry and Urethromanometry Catheters
      • U050101Cystomanometry Catheters, without Balloon
        • U05010101Cystomanometry Catheters, without Balloon, 2-WayMDR 100.0% Class IIa · n=30terminal

          Registered in EUDAMED under MDR with this code: 30 of 30 devices carry Class IIa on their registration (as of 8 Sep 2026).

          • 30 Class IIa (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.

        • U05010102Cystomanometry Catheters, without Balloon, 3-Wayterminal
      • U050199Cystomanometry and Urethromanometry Catheters - OtherMDR 100.0% Class IIa · n=53terminal

        Registered in EUDAMED under MDR with this code: 53 of 53 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 53 Class IIa (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.

    • U0502Urinary Pressure-Flow Study Catheters
      • U050201Filling Catheters for Urinary Pressure-Flow StudyMDR 100.0% Class IIa · n=27terminal

        Registered in EUDAMED under MDR with this code: 27 of 27 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 27 Class IIa (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.

      • U050202Bladder Pressure-Flow Study Cathetersterminal
      • U050299Urinary Pressure-Flow Study Catheters - Otherterminal
    • U0503Urethral Pressure Profile Catheters
      • U050301Urethral Pressure Profile Catheters without Balloon
        • U05030101Urethral Pressure Profile Catheters without Balloon, 1-Wayterminal
        • U05030102Urethral Pressure Profile Catheters without Balloon, 2-Wayterminal
      • U050399Urethral Pressure Profile Catheters - Otherterminal
    • U0504Intra-Abdominal Pressure Measurement Catheters
      • U050401Intra-Abdominal Pressure Measurement Catheters, without Balloonterminal
      • U050402Intra-Abdominal Pressure Measurement Catheters, with BalloonMDR 100.0% Class IIa · n=79terminal

        Registered in EUDAMED under MDR with this code: 79 of 79 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 79 Class IIa (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.

    • U0505Cavernosometry and Cavernosography Probesterminal
    • U0580Urodynamics Devices - AccessoriesMDR 2 classes · n=134terminal

      Registered in EUDAMED under MDR with this code, the 134 devices are split across classes (as of 8 Sep 2026).

      • 81 Class I (60.4%)
      • 53 Class IIa (39.5%)

      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.

    • U0599Urodynamics Devices - Otherterminal

How U05 is structured

14
terminal codes, selectable in a device record
6
branch headings, not selectable
9
name a specific device type
36%
fallback entries: Other and Accessories

The Urodynamics Devices branch runs 3 levels deep. 6 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 14 codes marked terminal.

4 terminal codes are “- Other” entries and 1 is an “- Accessories” entry, 36% 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 U0501 (Cystomanometry and Urethromanometry Catheters), holding 3 of the 14 terminal codes.

Frequently asked questions

Which U05 codes can be used in a EUDAMED device record?
14 of the 20 codes listed under U05 (Urodynamics Devices) are terminal and can be selected. The other 6 are branch headings that cannot.
How deep is the U05 hierarchy?
The U05 branch runs 3 levels below the group code. Its largest sub-branch is U0501 (Cystomanometry and Urethromanometry Catheters), which holds 3 of the 14 terminal codes.
How many U05 codes are catch-all entries?
4 terminal codes under U05 are "- Other" entries and 1 is an "- Accessories" entry, 36% of the branch. The remaining 9 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.

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Other groups in category U

U01Urethral, Prostatic and Bladder CathetersU02Ureteral Catheters and StentsU10Obstetrics DevicesU11Contraceptive DevicesU12Single-Use Instrumentation for Urogenital System (Non-Endoscopic)U13Solutions and Kits for Bladder Washing and InstillationU03Devices for Urethral, Ureteral and Nephrostomic DilationU04Devices for Percutaneous Urinary Drainage and Nephrostomy CathetersU06Urological GuidewiresU07Devices for the Treatment of IncontinenceU08Gynaecological DevicesU09Urogenital Endoscopic DevicesU14Non-Implantable Devices for Sexual DysfunctionU99Devices for Urogenital System - 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.