EMDN U11: Contraceptive Devices

Complete hierarchy for EMDN group U11 in category U (Devices for Urogenital System): 7 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.

  • U11Contraceptive Devices
    • U1101Male Contraceptive Devices
      • U110101CondomsMDR 100.0% Class IIb · n=2,289MDD 99.2% Class IIb · n=789terminal

        Registered in EUDAMED under MDR with this code: 2,289 of 2,289 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 2,289 Class IIb (100.0%)

        Registered in EUDAMED under MDD with this code: 783 of 789 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 783 Class IIb (99.2%)
        • 5 Class III (0.6%)
        • 1 Class IIa (0.1%)

        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.

      • U110102Devices for Ligation of the Vasa Deferentiaterminal
      • U110199Devices for Male Contraception - Otherterminal
    • U1102Devices for Female Contraception
      • U110201Intrauterine Coilsterminal
      • U110202Vaginal Diaphragmsterminal
      • U110203Female CondomsMDR 100.0% Class IIb · n=20terminal

        Registered in EUDAMED under MDR with this code: 20 of 20 devices carry Class IIb on their registration (as of 8 Sep 2026).

        • 20 Class IIb (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.

      • U110299Devices for Female Contraception - Otherterminal

How U11 is structured

7
terminal codes, selectable in a device record
2
branch headings, not selectable
5
name a specific device type
29%
fallback entries: Other and Accessories

The Contraceptive Devices branch runs 2 levels deep. 2 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 7 codes marked terminal.

2 terminal codes are “- Other” entries, 29% 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 U1102 (Devices for Female Contraception), holding 4 of the 7 terminal codes.

Frequently asked questions

Which U11 codes can be used in a EUDAMED device record?
7 of the 9 codes listed under U11 (Contraceptive Devices) are terminal and can be selected. The other 2 are branch headings that cannot.
How deep is the U11 hierarchy?
The U11 branch runs 2 levels below the group code. Its largest sub-branch is U1102 (Devices for Female Contraception), which holds 4 of the 7 terminal codes.
How many U11 codes are catch-all entries?
2 terminal codes under U11 are "- Other" entries, 29% of the branch. The remaining 5 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 Check

Other groups in category U

U01Urethral, Prostatic and Bladder CathetersU02Ureteral Catheters and StentsU10Obstetrics 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 CathetersU05Urodynamics 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.