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TOFscan

by Idmed France EUDAMED510(k)

Ref TF2-KIT, TOF-EMG, TF2-MU_ID, TF2-KIT-EMG_RU, PWR5-2_US, PWR5-2_UK, TOF-DS1Model TF2-System, TF2-Sensor, TOF-MU, TF2-PS, TOF-SinUseSensor510(k) K172690

Product code KOIEMDN Z1203019001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3665023TF2-SystemC3 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK172690 Date31 May 2018ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Trade Name
TOFscan
TOFscan (branded Idmed)
Device Name
TOFscan kit
TOFscan EMG sensor
Power supply for TOFscan
ToFscan AMG single use sensor
Model / Reference
TF2-System, TF2-KIT, TF2-Sensor, TOF-EMG, TOF-MU, TF2-MU_ID, TF2-KIT-EMG_RU, TF2-PS, PWR5-2_US, PWR5-2_UK, TOF-SinUseSensor, TOF-DS1
Primary DI / UDI-DI
03665023001433, 03665023001389, 03665023001372, 03665023002850, 03665023001402, 03665023001426, 03665023000580
Basic UDI-DI
3665023TF2-SystemC3, 3665023TF2-Sensor57, 3665023TOF-MUUJ, 3665023TF2-PSMF, 3665023TOF-SinUseSensorVX
Direct Marketing DI
03665023001433
03665023001389
03665023001372
03665023002850
03665023001402
03665023001426
03665023000580
EMDN Code
Z1203019001 Neuromuscular relaxation monitoring equipment
Device Class
Class IIa
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002402

Other devices from Idmed

See all devices from Idmed →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (8)

  • EUDAMED 54ab196d-8cc0-4120-b7ee-9bb3f52829c4 85 fields · synced 22 Oct 2026
  • EUDAMED 03665023001389|3665023TF2-SENSOR57 61 fields · synced 16 May 2026
  • EUDAMED 03665023001372|3665023TOF-MUUJ 61 fields · synced 17 May 2026
  • EUDAMED 03665023002850|3665023TF2-SYSTEMC3 61 fields · synced 18 May 2026
  • EUDAMED 03665023001402|3665023TF2-PSMF 61 fields · synced 18 May 2026
  • EUDAMED 03665023001426|3665023TF2-PSMF 61 fields · synced 18 May 2026
  • EUDAMED 03665023000580|3665023TOF-SINUSESENSORVX 61 fields · synced 18 May 2026
  • FDA 510(k) K172690 1 fields · synced 18 May 2026