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L52H

by FUJIFILM Corporation

Ref 04547410566949

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741050100000000000069Y Basic UDI-DI 04547410566949UDI-DIDate18 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410566949 UDI-DI Date29 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

4 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0190-2022 FDA Class II initiated 14 Oct 2021
    • Ongoing Z-0189-2022 FDA Class II initiated 14 Oct 2021

    Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

    • Ongoing Z-2308-2021 FDA Class II initiated 30 Jun 2021

    The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.

    • Terminated Z-1282-2021 FDA Class II initiated 1 Mar 2021

    Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Extracorporeal ultrasound imaging transducer, hand-held
Model / Reference
04547410566949 EUDAMED
L52H GUDID
Primary DI / UDI-DI
04547410566949
Basic UDI-DI
454741050100000000000069Y
Direct Marketing DI
04547410566949
510(k) Number
FDA Product Code
IYO, IYN, ITX
EMDN Code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560, 892.1550, 892.1570
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
High-level Disinfectant

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
04547410566949
GUDID
L52H
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000010401
Authorised representative
FUJIFILM Healthcare Europe GmbH DE-AR-000040920

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • 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