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FibroScan 530 Compact

by Echosens France EUDAMED510(k)GUDID

Ref FibroScan 530 Compact Model FibroScan 530 Compact

Product code IYOEMDN Z12040199

Overview

FibroScan 530 Compact is a non-invasive medical device that uses transient elastography to assess liver fibrosis and steatosis. It provides fast, point-of-care insights into liver stiffness and fat content without requiring biopsy or invasive procedures.

The device is reusable, non-sterile, and not implantable. It is classified as Class IIa under MDR and has received FDA 510(k) clearance (K123806). It is intended for use in clinical settings by trained professionals to support liver disease evaluation.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03662264001185 Basic UDI-DIDate3 Mar 2022RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03662264001185 Basic UDI-DIDate3 Mar 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK212035 Date30 Jul 2021IssuedStatusActive
United StatesGUDID listing GUDID Number03662264001185 UDI-DIDate5 Mar 2019ListedStatusIn distribution

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
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 23 Oct 2026

Full name
FibroScan
Generic Name
Hepatic ultrasound elastography system
Model / Reference
FibroScan 530 Compact
Primary DI / UDI-DI
03662264001185
Basic UDI-DI
B-03662264001185, 366226400000000000000066E
510(k) Number
FDA Product Code
IYO
EMDN Code
Z12040199 General medicine diagnosis and monitoring instruments - other
GMDN Term
Hepatic ultrasound elastography system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000003894

Other devices from Echosens

See all devices from Echosens →

Questions

  • What does FibroScan 530 Compact measure?

    FibroScan 530 Compact measures liver stiffness to assess fibrosis and controlled attenuation parameter (CAP) to evaluate steatosis (fat content) in the liver, using transient elastography technology.

  • Is FibroScan 530 Compact sterile or single-use?

    No, FibroScan 530 Compact is not sterile and is designed for reusable use. It does not require sterilization between uses and is not classified as a single-use device.

  • What regulatory clearances does FibroScan 530 Compact have?

    FibroScan 530 Compact has FDA 510(k) clearance (K123806), complies with MDD, and meets MDR requirements. It is classified as Class IIa under the applicable legislation.

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 (4)

  • EUDAMED 5c7dd3d0-f1f1-486d-aa54-4f84b238d4b6 61 fields · synced 23 Oct 2026
  • FDA UDI d9a8838e-baff-47c0-b112-80336b690149 35 fields · synced 30 May 2026
  • EUDAMED 03662264001185|366226400000000000000066E 61 fields · synced 15 Jul 2026
  • FDA 510(k) K212035 1 fields · synced 18 May 2026