eudamed_udi Primary ID: 03662264001185

FibroScan (UDI 03662264001185)

Manufactured by Echosens

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The FibroScan (Model/Catalog Number: FibroScan 530 Compact) is a medical device manufactured by Echosens. This product is indexed under FDA Product Code / Category Classification Z12040199 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: FibroScan 530 Compact
Product Code / EMDN: Z12040199
Device Name: FibroScan 530 Compact
Database Sync Date: 2026-08-09 16:46:08

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of FibroScan?

The registered manufacturer of record for FibroScan is Echosens.

What is the Primary UDI-DI identifier for FibroScan?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03662264001185.

What classification code is assigned to this device?

This device is registered under product classification code Z12040199.

Similar Classification Devices (Z12040199)

Other Devices by Echosens

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