EMDN U04: Devices for Percutaneous Urinary Drainage and Nephrostomy Catheters

Complete hierarchy for EMDN group U04 in category U (Devices for Urogenital System): 12 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.

  • U04Devices for Percutaneous Urinary Drainage and Nephrostomy Catheters
    • U0401Devices for Suprapubic Urinary Drainage
      • U040101Kits with Drainage Catheters, Direct Punctureterminal
      • U040102Kits with Drainage Catheters and IntroducersMDR 3 classes · n=193MDD 95.5% Class IIb · n=45terminal

        Registered in EUDAMED under MDR with this code, the 193 devices are split across classes (as of 8 Sep 2026).

        • 182 Class IIa (94.3%)
        • 7 Class I (3.6%)
        • 4 Class IIb (2.0%)

        Registered in EUDAMED under MDD with this code: 43 of 45 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 43 Class IIb (95.5%)
        • 2 Class IIa (4.4%)

        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.

      • U040199Devices for Suprapubic Urinary Drainage - OtherMDR 3 classes · n=369MDD 3 classes · n=354terminal

        Registered in EUDAMED under MDR with this code, the 369 devices are split across classes (as of 8 Sep 2026).

        • 242 Class IIb (65.5%)
        • 119 Class IIa (32.2%)
        • 8 Class I (2.1%)

        Registered in EUDAMED under MDD with this code, the 354 devices are split across classes (as of 8 Sep 2026).

        • 310 Class IIb (87.5%)
        • 27 Class IIa (7.6%)
        • 17 Class III (4.8%)

        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.

    • U0402Devices for Percutaneous Nephrostomy
      • U040201Nephrostomy Kits, Direct PunctureMDR 100.0% Class IIa · n=68MDD 100.0% Class IIa · n=30terminal

        Registered in EUDAMED under MDR with this code: 68 of 68 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 68 Class IIa (100.0%)

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

      • U040202Nephrostomy Kits, Seldinger MethodMDR 100.0% Class IIa · n=184MDD 2 classes · n=27terminal

        Registered in EUDAMED under MDR with this code: 184 of 184 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 184 Class IIa (100.0%)

        Registered in EUDAMED under MDD with this code, the 27 devices are split across classes (as of 8 Sep 2026).

        • 17 Class IIa (62.9%)
        • 10 Class IIb (37.0%)

        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.

      • U040203Nephrostomy CathetersMDR 97.8% Class IIa · n=190MDD 2 classes · n=588terminal

        Registered in EUDAMED under MDR with this code: 186 of 190 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 186 Class IIa (97.8%)
        • 4 Class III (2.1%)

        Registered in EUDAMED under MDD with this code, the 588 devices are split across classes (as of 8 Sep 2026).

        • 553 Class IIb (94.0%)
        • 35 Class IIa (5.9%)

        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.

      • U040299Devices for Percutaneous Nephrostomy - OtherMDR 99.3% Class IIa · n=165MDD 2 classes · n=39terminal

        Registered in EUDAMED under MDR with this code: 164 of 165 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 164 Class IIa (99.3%)
        • 1 Class I (0.6%)

        Registered in EUDAMED under MDD with this code, the 39 devices are split across classes (as of 8 Sep 2026).

        • 32 Class IIa (82.0%)
        • 7 Class IIb (17.9%)

        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.

    • U0403Devices for Ureteral Diversion and Ureterocutaneostomy
      • U040301Ureteral Diversion Probes, Bracciterminal
      • U040302Ureterocutaneostomy ProbesMDR 2 classes · n=46terminal

        Registered in EUDAMED under MDR with this code, the 46 devices are split across classes (as of 8 Sep 2026).

        • 30 Class IIb (65.2%)
        • 16 Class IIa (34.7%)

        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.

      • U040399Devices for Ureteral Diversion and Ureterocutaneostomy - Otherterminal
    • U0480Devices for Percutaneous Urinary Drainage - Accessoriesterminal
    • U0499Devices for Percutaneous Urinary Drainage - Otherterminal

How U04 is structured

12
terminal codes, selectable in a device record
3
branch headings, not selectable
7
name a specific device type
42%
fallback entries: Other and Accessories

The Devices for Percutaneous Urinary Drainage and Nephrostomy Catheters 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 12 codes marked terminal.

4 terminal codes are “- Other” entries and 1 is an “- Accessories” entry, 42% 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 U0402 (Devices for Percutaneous Nephrostomy), holding 4 of the 12 terminal codes.

Frequently asked questions

Which U04 codes can be used in a EUDAMED device record?
12 of the 15 codes listed under U04 (Devices for Percutaneous Urinary Drainage and Nephrostomy Catheters) are terminal and can be selected. The other 3 are branch headings that cannot.
How deep is the U04 hierarchy?
The U04 branch runs 2 levels below the group code. Its largest sub-branch is U0402 (Devices for Percutaneous Nephrostomy), which holds 4 of the 12 terminal codes.
How many U04 codes are catch-all entries?
4 terminal codes under U04 are "- Other" entries and 1 is an "- Accessories" entry, 42% 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.

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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 DilationU05Urodynamics DevicesU06Urological 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.