Which U08 codes can be used in a EUDAMED device record?

39 of the 49 codes listed under U08 (Gynaecological Devices) are terminal and can be selected. The other 10 are branch headings that cannot.

How many U08 codes are catch-all entries?

7 terminal codes under U08 are "- Other" entries and 2 are "- Accessories" entries, 23% of the branch. The remaining 30 name a specific device type.

EMDN U08: Gynaecological Devices

Complete hierarchy for EMDN group U08 in category U (Devices for Urogenital System): 39 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.

U08Gynaecological Devices
- U0801Gynaecological Catheters
  - U080101Catheters for Endometrial Ablationterminal
  - U080102Catheters for HysterosalpingographyMDD 2 classes · n=21terminal
    Registered in EUDAMED under MDD with this code, the 21 devices are split across classes (as of 8 Sep 2026).
    17 Class IIa (80.9%)
    4 Class I (19.0%)
    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.
  - U080103Catheters for Hysteroscopyterminal
  - U080199Gynaecological Catheters - OtherMDR 2 classes · n=23terminal
    Registered in EUDAMED under MDR with this code, the 23 devices are split across classes (as of 8 Sep 2026).
    13 Class IIa (56.5%)
    10 Class I (43.4%)
    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.
- U0802Devices for Assisted Reproduction
  - U080201Catheters for Assisted Reproduction
    - U08020101Catheters for Inseminationterminal
    - U08020102Catheters for Embryo TransferMDR 98.9% Class I · n=91terminal
      Registered in EUDAMED under MDR with this code: 90 of 91 devices carry Class I on their registration (as of 8 Sep 2026).
      90 Class I (98.9%)
      1 Class IIa (1.0%)
      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.
    - U08020180Assisted Reproduction Catheters - Accessoriesterminal
    - U08020199Assisted Reproduction Catheters - OtherMDR 100.0% Class I · n=37terminal
      Registered in EUDAMED under MDR with this code: 37 of 37 devices carry Class I on their registration (as of 8 Sep 2026).
      37 Class I (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.
  - U080202Needles and Sets for Oocyte Retrieval for Assisted Reproduction
    - U08020201Single Lumen Needles and Sets/Systems for Oocyte RetrievalMDR 100.0% Class IIa · n=70MDD 100.0% Class IIa · n=41terminal
      Registered in EUDAMED under MDR with this code: 70 of 70 devices carry Class IIa on their registration (as of 8 Sep 2026).
      70 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 41 of 41 devices carry Class IIa on their registration (as of 8 Sep 2026).
      41 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.
    - U08020202Double Lumen Needles and Sets/Systems for Oocyte RetrievalMDR 100.0% Class IIa · n=38terminal
      Registered in EUDAMED under MDR with this code: 38 of 38 devices carry Class IIa on their registration (as of 8 Sep 2026).
      38 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.
  - U080203Devices for Micromanipulation of Biological Material for Assisted Reproduction
    - U08020301Pipettes for Assisted Reproduction
      - U0802030101Biopsy Pipettes for Assisted ReproductionMDR 100.0% Class I · n=100MDD 100.0% Class IIa · n=34terminal
        Registered in EUDAMED under MDR with this code: 100 of 100 devices carry Class I on their registration (as of 8 Sep 2026).
        100 Class I (100.0%)
        Registered 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.
      - U0802030102Denuding PipettesMDR 2 classes · n=45terminal
        Registered in EUDAMED under MDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).
        40 Class I (88.8%)
        5 Class IIa (11.1%)
        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.
      - U0802030103Handling Pipettesterminal
      - U0802030104Hatching/Drilling PipettesMDR 100.0% Class I · n=21terminal
        Registered in EUDAMED under MDR with this code: 21 of 21 devices carry Class I on their registration (as of 8 Sep 2026).
        21 Class I (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.
      - U0802030105Holding PipettesMDR 100.0% Class I · n=46MDD 100.0% Class IIa · n=34terminal
        Registered in EUDAMED under MDR with this code: 46 of 46 devices carry Class I on their registration (as of 8 Sep 2026).
        46 Class I (100.0%)
        Registered 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.
      - U0802030106Icsi PipettesMDR 100.0% Class I · n=115MDD 98.4% Class IIa · n=64terminal
        Registered in EUDAMED under MDR with this code: 115 of 115 devices carry Class I on their registration (as of 8 Sep 2026).
        115 Class I (100.0%)
        Registered in EUDAMED under MDD with this code: 63 of 64 devices carry Class IIa on their registration (as of 8 Sep 2026).
        63 Class IIa (98.4%)
        1 Class I (1.5%)
        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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - U0802030107Pasteur Pipettes for Assisted Reproductionterminal
      - U0802030108Pzd PipettesMDD 100.0% Class IIa · n=20terminal
        Registered in EUDAMED under MDD with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
        20 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.
      - U0802030199Pipettes for Assisted Reproduction - Otherterminal
    - U08020302Systems for Micromanipulation of Biological Material for Assisted Reproduction
      - U0802030201Tips for Assisted ReproductionMDR 100.0% Class IIb · n=47terminal
        Registered in EUDAMED under MDR with this code: 47 of 47 devices carry Class IIb on their registration (as of 8 Sep 2026).
        47 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.
      - U0802030202Handpieces for Tips for Assisted Reproductionterminal
    - U08020380Devices for Micromanipulation of Biological Material for Assisted Reproduction - AccessoriesMDR 100.0% Class I · n=27terminal
      Registered in EUDAMED under MDR with this code: 27 of 27 devices carry Class I on their registration (as of 8 Sep 2026).
      27 Class I (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.
    - U08020399Devices for Micromanipulation of Biological Material for Assisted Reproduction - Otherterminal
  - U080204Cryopreservation Containers/Sets for Assisted Reproduction
    - U08020401Cryopreservation Containers/Straws/Vials for Assisted ReproductionMDR 2 classes · n=74MDD 100.0% Class IIa · n=26terminal
      Registered in EUDAMED under MDR with this code, the 74 devices are split across classes (as of 8 Sep 2026).
      49 Class IIa (66.2%)
      25 Class I (33.7%)
      Registered in EUDAMED under MDD with this code: 26 of 26 devices carry Class IIa on their registration (as of 8 Sep 2026).
      26 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.
  - U080205Substrates for Storing/Handling Biological Material for Assisted Reproduction
    - U08020501Materials/Solutions for Freezing/Thawing for Assisted Reproductionterminal
    - U08020502Materials/Solutions for Preparation/Handling for Assisted ReproductionMDR 2 classes · n=47MDD 3 classes · n=53terminal
      Registered in EUDAMED under MDR with this code, the 47 devices are split across classes (as of 8 Sep 2026).
      30 Class IIa (63.8%)
      17 Class III (36.1%)
      Registered in EUDAMED under MDD with this code, the 53 devices are split across classes (as of 8 Sep 2026).
      42 Class III (79.2%)
      7 Class IIb (13.2%)
      4 Class IIa (7.5%)
      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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - U08020503Materials/Culture Media for Assisted ReproductionMDR 2 classes · n=22terminal
      Registered in EUDAMED under MDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).
      12 Class IIa (54.5%)
      10 Class III (45.4%)
      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.
    - U08020599Substrates for Storing/Handling Biological Material for Assisted Reproduction - Otherterminal
  - U080206Culture Plates for Assisted ReproductionMDR 100.0% Class IIa · n=51terminal
    Registered in EUDAMED under MDR with this code: 51 of 51 devices carry Class IIa on their registration (as of 8 Sep 2026).
    51 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.
  - U080207Containers for Preparation of Biological Material for Assisted ReproductionMDR 97.1% Class IIa · n=35terminal
    Registered in EUDAMED under MDR with this code: 34 of 35 devices carry Class IIa on their registration (as of 8 Sep 2026).
    34 Class IIa (97.1%)
    1 Class I (2.8%)
    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.
  - U080299Devices for Assisted Reproduction - OtherMDR 3 classes · n=86MDD 2 classes · n=24terminal
    Registered in EUDAMED under MDR with this code, the 86 devices are split across classes (as of 8 Sep 2026).
    48 Class I (55.8%)
    37 Class IIa (43.0%)
    1 Class IIb (1.1%)
    Registered in EUDAMED under MDD with this code, the 24 devices are split across classes (as of 8 Sep 2026).
    18 Class IIa (75.0%)
    6 Class I (25.0%)
    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.
- U0803Vaginal Devices in the Form of Solutions/Creams/Ova/TabletsMDR 96.7% Class IIb · n=183MDD 4 classes · n=509terminal
  Registered in EUDAMED under MDR with this code: 177 of 183 devices carry Class IIb on their registration (as of 8 Sep 2026).
  - 177 Class IIb (96.7%)
  - 4 Class IIa (2.1%)
  - 2 Class I (1.0%)
  Registered in EUDAMED under MDD with this code, the 509 devices are split across classes (as of 8 Sep 2026).
  - 475 Class IIa (93.3%)
  - 30 Class I (5.8%)
  - 2 Class IIb (0.3%)
  - 2 Class III (0.3%)
  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.
- U0890Devices for Gynecology - Various
  - U089002Devices for Gynaecological CytologyMDR 95.0% Class I · n=300terminal
    Registered in EUDAMED under MDR with this code: 285 of 300 devices carry Class I on their registration (as of 8 Sep 2026).
    285 Class I (95.0%)
    15 Class IIa (5.0%)
    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.
  - U089003Hysterometers, Single-Useterminal
  - U089005PessariansMDR 3 classes · n=340MDD 2 classes · n=454terminal
    Registered in EUDAMED under MDR with this code, the 340 devices are split across classes (as of 8 Sep 2026).
    224 Class IIa (65.8%)
    98 Class IIb (28.8%)
    18 Class I (5.2%)
    Registered in EUDAMED under MDD with this code, the 454 devices are split across classes (as of 8 Sep 2026).
    250 Class IIa (55.0%)
    204 Class IIb (44.9%)
    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.
  - U089006Vaginal Speculum, Single-UseMDR 96.6% Class I · n=501MDD 100.0% Class I · n=239terminal
    Registered in EUDAMED under MDR with this code: 484 of 501 devices carry Class I on their registration (as of 8 Sep 2026).
    484 Class I (96.6%)
    17 Class IIa (3.3%)
    Registered in EUDAMED under MDD with this code: 239 of 239 devices carry Class I on their registration (as of 8 Sep 2026).
    239 Class I (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.
  - U089009Vaginal Applicators, Single-UseMDR 100.0% Class I · n=34terminal
    Registered in EUDAMED under MDR with this code: 34 of 34 devices carry Class I on their registration (as of 8 Sep 2026).
    34 Class I (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.
  - U089010Uterine Curettes, Single-UseMDR 2 classes · n=38MDD 2 classes · n=88terminal
    Registered in EUDAMED under MDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).
    33 Class I (86.8%)
    5 Class IIa (13.1%)
    Registered in EUDAMED under MDD with this code, the 88 devices are split across classes (as of 8 Sep 2026).
    63 Class I (71.5%)
    25 Class IIa (28.4%)
    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.
- U0899Gynaecological Devices - OtherMDR 4 classes · n=565MDD 2 classes · n=88terminal
  Registered in EUDAMED under MDR with this code, the 565 devices are split across classes (as of 8 Sep 2026).
  - 392 Class I (69.3%)
  - 89 Class IIa (15.7%)
  - 83 Class IIb (14.6%)
  - 1 Class III (0.1%)
  Registered in EUDAMED under MDD with this code, the 88 devices are split across classes (as of 8 Sep 2026).
  - 47 Class I (53.4%)
  - 41 Class IIa (46.5%)
  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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

How U08 is structured

terminal codes, selectable in a device record

branch headings, not selectable

name a specific device type

23%

fallback entries: Other and Accessories

The Gynaecological Devices branch runs 4 levels deep. 10 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 39 codes marked terminal.

7 terminal codes are “- Other” entries and 2 are “- Accessories” entries, 23% 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 U0802 (Devices for Assisted Reproduction), holding 27 of the 39 terminal codes.

Frequently asked questions

Which U08 codes can be used in a EUDAMED device record?: 39 of the 49 codes listed under U08 (Gynaecological Devices) are terminal and can be selected. The other 10 are branch headings that cannot.
How deep is the U08 hierarchy?: The U08 branch runs 4 levels below the group code. Its largest sub-branch is U0802 (Devices for Assisted Reproduction), which holds 27 of the 39 terminal codes.
How many U08 codes are catch-all entries?: 7 terminal codes under U08 are "- Other" entries and 2 are "- Accessories" entries, 23% of the branch. The remaining 30 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 Catheters U02Ureteral Catheters and Stents U10Obstetrics Devices U11Contraceptive Devices U12Single-Use Instrumentation for Urogenital System (Non-Endoscopic)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 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.