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.

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.

U12Single-Use Instrumentation for Urogenital System (Non-Endoscopic)
- U1201Non-Endoscopic Single-Use Forceps for Urogenital Systemterminal
- U1202Single-Use Non-Endoscopic Urogenital Scissorsterminal
- U1299Single-Use Urogenital Instrumentation (Non-Endoscopic) - Otherterminal

How U12 is structured

terminal codes, selectable in a device record

branch headings, not selectable

name a specific device type

33%

fallback entries: Other and Accessories

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.

Classifying more than a handful of devices?

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Other groups in category U

U01Urethral, Prostatic and Bladder Catheters U02Ureteral Catheters and Stents U10Obstetrics Devices U11Contraceptive Devices U13Solutions and Kits for Bladder Washing and Instillation U03Devices for Urethral, Ureteral and Nephrostomic Dilation U04Devices for Percutaneous Urinary Drainage and Nephrostomy Catheters U05Urodynamics Devices U06Urological Guidewires U07Devices for the Treatment of Incontinence U08Gynaecological Devices U09Urogenital Endoscopic Devices U14Non-Implantable Devices for Sexual Dysfunction U99Devices 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.