Which K01 codes can be used in a EUDAMED device record?

45 of the 51 codes listed under K01 (Endotherapy Devices) are terminal and can be selected. The other 6 are branch headings that cannot.

How many K01 codes are catch-all entries?

5 terminal codes under K01 are "- Other" entries and 2 are "- Accessories" entries, 16% of the branch. The remaining 38 name a specific device type.

EMDN K01: Endotherapy Devices

Complete hierarchy for EMDN group K01 in category K (Endotherapy and Electrosurgical Devices): 45 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.

K01Endotherapy Devices
- K0101Trocar and Kits, Single-Use
  - K010101Trocar, Single-Use
    - K01010101Trocar Standard, Single-UseMDR 99.5% Class IIa · n=1,309MDD 100.0% Class IIa · n=1,502terminal
      Registered in EUDAMED under MDR with this code: 1,303 of 1,309 devices carry Class IIa on their registration (as of 8 Sep 2026).
      1,303 Class IIa (99.5%)
      6 Class IIb (0.4%)
      Registered in EUDAMED under MDD with this code: 1,502 of 1,502 devices carry Class IIa on their registration (as of 8 Sep 2026).
      1,502 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.
    - K01010102Hasson Trocar, Single-UseMDR 100.0% Class IIa · n=64terminal
      Registered in EUDAMED under MDR with this code: 64 of 64 devices carry Class IIa on their registration (as of 8 Sep 2026).
      64 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.
    - K01010103Optical Trocar, Single-UseMDR 2 classes · n=458MDD 100.0% Class IIa · n=104terminal
      Registered in EUDAMED under MDR with this code, the 458 devices are split across classes (as of 8 Sep 2026).
      306 Class IIa (66.8%)
      152 Class I (33.1%)
      Registered in EUDAMED under MDD with this code: 104 of 104 devices carry Class IIa on their registration (as of 8 Sep 2026).
      104 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.
    - K01010104Thoracic Trocar, Single-Useterminal
    - K01010105Special Trocar, Single-UseMDR 100.0% Class IIa · n=66terminal
      Registered in EUDAMED under MDR with this code: 66 of 66 devices carry Class IIa on their registration (as of 8 Sep 2026).
      66 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.
    - K01010106Robotic Surgery Trocar, Single-Useterminal
    - K01010180Trocar, Single-Use - AccessoriesMDD 100.0% Class IIa · n=92terminal
      Registered in EUDAMED under MDD with this code: 92 of 92 devices carry Class IIa on their registration (as of 8 Sep 2026).
      92 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.
    - K01010199Trocar, Single-Use - OtherMDR 100.0% Class IIa · n=128MDD 100.0% Class IIa · n=51terminal
      Registered in EUDAMED under MDR with this code: 128 of 128 devices carry Class IIa on their registration (as of 8 Sep 2026).
      128 Class IIa (100.0%)
      Registered in EUDAMED under MDD 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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - K010102Minimally Invasive Surgery Kits, Single-UseMDR 2 classes · n=191MDD 100.0% Class IIa · n=20terminal
    Registered in EUDAMED under MDR with this code, the 191 devices are split across classes (as of 8 Sep 2026).
    172 Class IIa (90.0%)
    19 Class IIb (9.9%)
    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.
- K0102Minimally Invasive and Robotic Surgery Instruments, Single-Use
  - K010201Minimally Invasive Surgery Surgical Instruments, Single-Use
    - K01020101Minimally Invasive Surgery Dissectors, Single-UseMDR 97.0% Class IIa · n=102MDD 2 classes · n=27terminal
      Registered in EUDAMED under MDR with this code: 99 of 102 devices carry Class IIa on their registration (as of 8 Sep 2026).
      99 Class IIa (97.0%)
      2 Class IIb (1.9%)
      1 Class I (0.9%)
      Registered in EUDAMED under MDD with this code, the 27 devices are split across classes (as of 8 Sep 2026).
      18 Class IIa (66.6%)
      9 Class IIb (33.3%)
      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.
    - K01020102Minimally Invasive Surgery Scissors, Single-UseMDR 3 classes · n=66MDD 3 classes · n=212terminal
      Registered in EUDAMED under MDR with this code, the 66 devices are split across classes (as of 8 Sep 2026).
      47 Class IIa (71.2%)
      17 Class I (25.7%)
      2 Class IIb (3.0%)
      Registered in EUDAMED under MDD with this code, the 212 devices are split across classes (as of 8 Sep 2026).
      195 Class IIa (91.9%)
      15 Class I (7.0%)
      2 Class IIb (0.9%)
      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.
    - K01020103Minimally Invasive Surgery Manipulators, Single-Useterminal
    - K01020104Minimally Invasive Surgery Forceps, Single-UseMDR 3 classes · n=223MDD 95.3% Class IIa · n=412terminal
      Registered in EUDAMED under MDR with this code, the 223 devices are split across classes (as of 8 Sep 2026).
      199 Class IIa (89.2%)
      23 Class I (10.3%)
      1 Class IIb (0.4%)
      Registered in EUDAMED under MDD with this code: 393 of 412 devices carry Class IIa on their registration (as of 8 Sep 2026).
      393 Class IIa (95.3%)
      18 Class I (4.3%)
      1 Class III (0.2%)
      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.
    - K01020105Minimally Invasive Surgery Needle Holders, Single-UseMDR 100.0% Class IIa · n=37MDD 100.0% Class IIa · n=48terminal
      Registered in EUDAMED under MDR with this code: 37 of 37 devices carry Class IIa on their registration (as of 8 Sep 2026).
      37 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 48 of 48 devices carry Class IIa on their registration (as of 8 Sep 2026).
      48 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.
    - K01020106Minimally Invasive Surgery Spreaders and Retractors, Single-UseMDR 98.4% Class IIa · n=326MDD 2 classes · n=209terminal
      Registered in EUDAMED under MDR with this code: 321 of 326 devices carry Class IIa on their registration (as of 8 Sep 2026).
      321 Class IIa (98.4%)
      5 Class I (1.5%)
      Registered in EUDAMED under MDD with this code, the 209 devices are split across classes (as of 8 Sep 2026).
      183 Class IIa (87.5%)
      26 Class III (12.4%)
      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.
    - K01020107Minimally Invasive Surgery Recovery BagsMDR 99.3% Class IIa · n=156MDD 99.5% Class IIa · n=248terminal
      Registered in EUDAMED under MDR with this code: 155 of 156 devices carry Class IIa on their registration (as of 8 Sep 2026).
      155 Class IIa (99.3%)
      1 Class I (0.6%)
      Registered in EUDAMED under MDD with this code: 247 of 248 devices carry Class IIa on their registration (as of 8 Sep 2026).
      247 Class IIa (99.5%)
      1 Class I (0.4%)
      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.
    - K01020109Minimally Invasive Surgery Swabsterminal
    - K01020110Minimally Invasive Surgery Cannulas, Single-UseMDR 2 classes · n=161MDD 2 classes · n=88terminal
      Registered in EUDAMED under MDR with this code, the 161 devices are split across classes (as of 8 Sep 2026).
      151 Class IIa (93.7%)
      10 Class I (6.2%)
      Registered in EUDAMED under MDD with this code, the 88 devices are split across classes (as of 8 Sep 2026).
      82 Class IIa (93.1%)
      6 Class I (6.8%)
      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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - K01020111Minimally Invasive Surgery Blades, Single-Useterminal
    - K01020112Minimally Invasive Surgery Hooks, Single-UseMDR 97.1% Class IIa · n=70MDD 100.0% Class IIa · n=24terminal
      Registered in EUDAMED under MDR with this code: 68 of 70 devices carry Class IIa on their registration (as of 8 Sep 2026).
      68 Class IIa (97.1%)
      2 Class I (2.8%)
      Registered in EUDAMED under MDD with this code: 24 of 24 devices carry Class IIa on their registration (as of 8 Sep 2026).
      24 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.
    - K01020113Minimally Invasive Surgery Spatulas, Single-Useterminal
    - K01020114Minimally Invasive Surgery Guides, Single-UseMDR 100.0% Class IIa · n=4,301terminal
      Registered in EUDAMED under MDR with this code: 4,301 of 4,301 devices carry Class IIa on their registration (as of 8 Sep 2026).
      4,301 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.
    - K01020115Minimally Invasive Surgery Handpieces, Single-Useterminal
    - K01020116Endoscopic Tissue Suture Approximators, Single - UseMDD 100.0% Class IIa · n=24terminal
      Registered in EUDAMED under MDD with this code: 24 of 24 devices carry Class IIa on their registration (as of 8 Sep 2026).
      24 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.
    - K01020117Minimally Invasive Surgery Dilators, Single-UseMDR 2 classes · n=34terminal
      Registered in EUDAMED under MDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).
      31 Class IIa (91.1%)
      3 Class I (8.8%)
      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.
    - K01020118Minimally Invasive Surgery Needles, Single-Useterminal
    - K01020119Minimally Invasive Surgery Palpators, Single Useterminal
    - K01020120Minimally Invasive Surgery Surgical Instrument Kits, Single-UseMDR 4 classes · n=132MDD 100.0% Class IIa · n=34terminal
      Registered in EUDAMED under MDR with this code, the 132 devices are split across classes (as of 8 Sep 2026).
      113 Class IIa (85.6%)
      16 Class IIb (12.1%)
      2 Class III (1.5%)
      1 Class I (0.7%)
      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.
    - K01020199Minimally Invasive Surgery Surgical Instrument Kits, Single-Use - OtherMDR 3 classes · n=91MDD 2 classes · n=25terminal
      Registered in EUDAMED under MDR with this code, the 91 devices are split across classes (as of 8 Sep 2026).
      80 Class IIa (87.9%)
      10 Class I (10.9%)
      1 Class IIb (1.0%)
      Registered in EUDAMED under MDD with this code, the 25 devices are split across classes (as of 8 Sep 2026).
      22 Class IIa (88.0%)
      3 Class IIb (12.0%)
      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.
  - K010202Robotic Surgery Instruments, Single-Use
    - K01020201Robotic Surgery Scalpels and Blades, Single-Useterminal
    - K01020202Robotic Surgery Clips, Single-Useterminal
    - K01020203Robotic Surgery Scissors, Single-Useterminal
    - K01020204Robotic Surgery Forceps, Single-Useterminal
    - K01020205Robotic Surgery Instrument Kits, Single-Useterminal
    - K01020299Robotic Surgery Instrument, Single-Use - OtherMDR 3 classes · n=48terminal
      Registered in EUDAMED under MDR with this code, the 48 devices are split across classes (as of 8 Sep 2026).
      31 Class I (64.5%)
      11 Class IIa (22.9%)
      6 Class IIb (12.5%)
      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.
- K0103Spinal Endotherapy Devices
  - K010301Spinal Percutaneous Plastic Devices with BalloonMDR 100.0% Class IIa · n=191MDD 99.7% Class IIa · n=460terminal
    Registered in EUDAMED under MDR with this code: 191 of 191 devices carry Class IIa on their registration (as of 8 Sep 2026).
    191 Class IIa (100.0%)
    Registered in EUDAMED under MDD with this code: 459 of 460 devices carry Class IIa on their registration (as of 8 Sep 2026).
    459 Class IIa (99.7%)
    1 Class I (0.2%)
    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.
  - K010302Minimally Invasive Spinal Surgery Instruments, Single-UseMDD 100.0% Class IIa · n=27terminal
    Registered in EUDAMED under MDD with this code: 27 of 27 devices carry Class IIa on their registration (as of 8 Sep 2026).
    27 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.
  - K010399Spinal Endotherapy Devices - OtherMDR 96.9% Class I · n=196terminal
    Registered in EUDAMED under MDR with this code: 190 of 196 devices carry Class I on their registration (as of 8 Sep 2026).
    190 Class I (96.9%)
    5 Class IIa (2.5%)
    1 Class IIb (0.5%)
    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.
- K0104Veress NeedlesMDR 100.0% Class IIa · n=51MDD 96.0% Class IIa · n=76terminal
  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%)
  Registered in EUDAMED under MDD with this code: 73 of 76 devices carry Class IIa on their registration (as of 8 Sep 2026).
  - 73 Class IIa (96.0%)
  - 2 Class I (2.6%)
  - 1 Class IIb (1.3%)
  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.
- K0105Minimally Invasive Surgery Stability Screw Threadsterminal
- K0106Minimally Invasive Surgery Reducersterminal
- K0107Cholangiography Probesterminal
- K0108Hand-Assisted Surgery Devicesterminal
- K0180Endotherapy Devices - Other AccessoriesMDR 2 classes · n=37MDD 95.6% Class IIa · n=23terminal
  Registered in EUDAMED under MDR with this code, the 37 devices are split across classes (as of 8 Sep 2026).
  - 29 Class IIa (78.3%)
  - 8 Class I (21.6%)
  Registered in EUDAMED under MDD with this code: 22 of 23 devices carry Class IIa on their registration (as of 8 Sep 2026).
  - 22 Class IIa (95.6%)
  - 1 Class I (4.3%)
  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.
- K0199Endotherapy Devices - OtherMDR 3 classes · n=106MDD 96.0% Class IIa · n=25terminal
  Registered in EUDAMED under MDR with this code, the 106 devices are split across classes (as of 8 Sep 2026).
  - 69 Class IIa (65.0%)
  - 21 Class I (19.8%)
  - 16 Class IIb (15.0%)
  Registered in EUDAMED under MDD with this code: 24 of 25 devices carry Class IIa on their registration (as of 8 Sep 2026).
  - 24 Class IIa (96.0%)
  - 1 Class IIb (4.0%)
  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 K01 is structured

terminal codes, selectable in a device record

branch headings, not selectable

name a specific device type

16%

fallback entries: Other and Accessories

The Endotherapy Devices branch runs 3 levels deep. 6 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 45 codes marked terminal.

5 terminal codes are “- Other” entries and 2 are “- Accessories” entries, 16% 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 K0102 (Minimally Invasive and Robotic Surgery Instruments, Single-Use), holding 26 of the 45 terminal codes.

Frequently asked questions

Which K01 codes can be used in a EUDAMED device record?: 45 of the 51 codes listed under K01 (Endotherapy Devices) are terminal and can be selected. The other 6 are branch headings that cannot.
How deep is the K01 hierarchy?: The K01 branch runs 3 levels below the group code. Its largest sub-branch is K0102 (Minimally Invasive and Robotic Surgery Instruments, Single-Use), which holds 26 of the 45 terminal codes.
How many K01 codes are catch-all entries?: 5 terminal codes under K01 are "- Other" entries and 2 are "- Accessories" entries, 16% of the branch. The remaining 38 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 K

K02Electrosurgery Devices, Single-Use K03Arthroscopy Devices, Single-Use

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.