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iLOOK P35004-04

by Fujifilm Sonosite, Inc. United States EUDAMEDGUDID

Ref P35004Model AC-DC POWER SUPPLY

Product code ITXEMDN Z1104018099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08415171powersupplyR9 Basic UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841517112462 UDI-DIDate16 Jul 2026ListedStatusIn distribution

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
AC-DC POWER SUPPLY, SONOSITE iLOOK EUDAMED
iLOOK GUDID
Generic Name
Basic power supply, reusable
Model / Ref / Catalog
AC-DC POWER SUPPLY, P35004, P35004-04
Primary DI / UDI-DI
00841517112462
Basic UDI-DI
08415171powersupplyR9
510(k) Number
FDA Product Code
ITX, IYN, IYO
EMDN Code
Z1104018099 Ultrasound scanners – hardware accessories – other
GMDN Term
Basic power supply, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550, 892.1560
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AC-DC POWER SUPPLY
P35004
GUDID
P35004-04
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K260595)

Other devices from Fujifilm Sonosite, Inc.

See all devices from Fujifilm Sonosite, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • FDA UDI 429782fe-51b4-4402-b6a2-f77e4ad1f24d 36 fields · synced 24 Oct 2026
  • EUDAMED 00841517112462|08415171POWERSUPPLYR9 61 fields · synced 24 Oct 2026