EMDN U12: Single-Use Instrumentation for Urogenital System (Non-Endoscopic)
Complete hierarchy for EMDN group U12 in category U (Devices for Urogenital System): 3 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.
U12Single-Use Instrumentation for Urogenital System (Non-Endoscopic)U1201Non-Endoscopic Single-Use Forceps for Urogenital SystemterminalU1202Single-Use Non-Endoscopic Urogenital ScissorsterminalU1299Single-Use Urogenital Instrumentation (Non-Endoscopic) - OtherMDD 100.0% Class IIa · n=34terminalRegistered in EUDAMED under MDD with this code: 34 of 34 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 34 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.
How U12 is structured
The Single-Use Instrumentation for Urogenital System (Non-Endoscopic) branch runs 1 level deep. Every code below is terminal.
1 terminal code is an “- Other” entry, 33% 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 U12 codes can be used in a EUDAMED device record?
- All 3 codes listed under U12 (Single-Use Instrumentation for Urogenital System (Non-Endoscopic)) are terminal, so any of them can be selected in a device record.
- How deep is the U12 hierarchy?
- The U12 branch runs 1 level below the group code.
- How many U12 codes are catch-all entries?
- 1 terminal code under U12 is an "- Other" entry, 33% of the branch. The remaining 2 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 CheckOther groups in category U
U01Urethral, Prostatic and Bladder CathetersU02Ureteral Catheters and StentsU10Obstetrics DevicesU11Contraceptive DevicesU13Solutions and Kits for Bladder Washing and InstillationU03Devices for Urethral, Ureteral and Nephrostomic DilationU04Devices for Percutaneous Urinary Drainage and Nephrostomy CathetersU05Urodynamics DevicesU06Urological GuidewiresU07Devices for the Treatment of IncontinenceU08Gynaecological DevicesU09Urogenital Endoscopic DevicesU14Non-Implantable Devices for Sexual DysfunctionU99Devices for Urogenital System - OtherSource: 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.