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.

  • U08Gynaecological Devices
    • U0801Gynaecological Catheters
      • U080101Catheters for Endometrial Ablationterminal
      • U080102Catheters for Hysterosalpingographyterminal
      • U080103Catheters for Hysteroscopyterminal
      • U080199Gynaecological Catheters - Otherterminal
    • U0802Devices for Assisted Reproduction
      • U080201Catheters for Assisted Reproduction
        • U08020101Catheters for Inseminationterminal
        • U08020102Catheters for Embryo Transferterminal
        • U08020180Assisted Reproduction Catheters - Accessoriesterminal
        • U08020199Assisted Reproduction Catheters - Otherterminal
      • U080202Needles and Sets for Oocyte Retrieval for Assisted Reproduction
        • U08020201Single Lumen Needles and Sets/Systems for Oocyte Retrievalterminal
        • U08020202Double Lumen Needles and Sets/Systems for Oocyte Retrievalterminal
      • U080203Devices for Micromanipulation of Biological Material for Assisted Reproduction
        • U08020301Pipettes for Assisted Reproduction
          • U0802030101Biopsy Pipettes for Assisted Reproductionterminal
          • U0802030102Denuding Pipettesterminal
          • U0802030103Handling Pipettesterminal
          • U0802030104Hatching/Drilling Pipettesterminal
          • U0802030105Holding Pipettesterminal
          • U0802030106Icsi Pipettesterminal
          • U0802030107Pasteur Pipettes for Assisted Reproductionterminal
          • U0802030108Pzd Pipettesterminal
          • U0802030199Pipettes for Assisted Reproduction - Otherterminal
        • U08020302Systems for Micromanipulation of Biological Material for Assisted Reproduction
          • U0802030201Tips for Assisted Reproductionterminal
          • U0802030202Handpieces for Tips for Assisted Reproductionterminal
        • U08020380Devices for Micromanipulation of Biological Material for Assisted Reproduction - Accessoriesterminal
        • U08020399Devices for Micromanipulation of Biological Material for Assisted Reproduction - Otherterminal
      • U080204Cryopreservation Containers/Sets for Assisted Reproduction
        • U08020401Cryopreservation Containers/Straws/Vials for Assisted Reproductionterminal
      • U080205Substrates for Storing/Handling Biological Material for Assisted Reproduction
        • U08020501Materials/Solutions for Freezing/Thawing for Assisted Reproductionterminal
        • U08020502Materials/Solutions for Preparation/Handling for Assisted Reproductionterminal
        • U08020503Materials/Culture Media for Assisted Reproductionterminal
        • U08020599Substrates for Storing/Handling Biological Material for Assisted Reproduction - Otherterminal
      • U080206Culture Plates for Assisted Reproductionterminal
      • U080207Containers for Preparation of Biological Material for Assisted Reproductionterminal
      • U080299Devices for Assisted Reproduction - Otherterminal
    • U0803Vaginal Devices in the Form of Solutions/Creams/Ova/Tabletsterminal
    • U0890Devices for Gynecology - Various
      • U089002Devices for Gynaecological Cytologyterminal
      • U089003Hysterometers, Single-Useterminal
      • U089005Pessariansterminal
      • U089006Vaginal Speculum, Single-Useterminal
      • U089009Vaginal Applicators, Single-Useterminal
      • U089010Uterine Curettes, Single-Useterminal
    • U0899Gynaecological Devices - Otherterminal

How U08 is structured

39
terminal codes, selectable in a device record
10
branch headings, not selectable
30
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.

Classifying more than a handful of devices?

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Other groups in category U

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.