Skip to content

WiTOF

by Idmed France EUDAMED510(k)GUDID

Ref WiTOF-FS, WiTOF-DEMO, WiTOF-MUModel WiTOF-Sensor, WiTOF-System

Product code KOIEMDN Z1203019001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03665023000573 UDI-DIDate19 Dec 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number3665023WiTOF-SensorG5 Basic UDI-DIDate4 Nov 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK243339 Date23 Jun 2025IssuedStatusActive

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 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
WiTOF EUDAMEDGUDID
WiTOF (branded Idmed) EUDAMED
Generic Name
Neuromuscular transmission lead set
Device Name
WiTOF Sensor
WiTOF kit
Model / Ref / Catalog
WiTOF-Sensor, WiTOF-FS, WiTOF-System, WiTOF-DEMO, WiTOF-MU
Primary DI / UDI-DI
03665023000573, 03665023000610, 03665023000535
Basic UDI-DI
3665023WiTOF-SensorG5, 3665023WiTOF-SystemNZ, 3665023WiTOF-MUR2
Direct Marketing DI
03665023000573
03665023000610
03665023000535
510(k) Number
FDA Product Code
KOI
EMDN Code
Z1203019001 Neuromuscular relaxation monitoring equipment
GMDN Term
Neuromuscular transmission lead set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.2775
Market of Registration
France
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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
  • Prescription Use
  • Convenience Kit YesGUDIDNoGUDID
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (7)

  • EUDAMED 0e76c0be-d946-47af-b1c3-52eb366445b5 61 fields · synced 24 Oct 2026
  • EUDAMED 03665023000610|3665023WITOF-SYSTEMNZ 61 fields · synced 16 May 2026
  • EUDAMED 03665023000535|3665023WITOF-MUR2 61 fields · synced 17 May 2026
  • FDA UDI 702024e0-d837-4c56-bf5a-e77b87ef7436 34 fields · synced 23 Oct 2026
  • FDA UDI cbaa51be-38bb-4728-9cbb-7f0e1feabe82 34 fields · synced 23 Oct 2026
  • FDA UDI 60a2bc13-c9c1-4e79-a1c8-9991e37c9331 35 fields · synced 23 Oct 2026
  • FDA 510(k) K243339 1 fields · synced 18 May 2026