GUDIDData
gudid Primary ID: 04U0001

Alinity (UDI 04U0001)

Manufactured by ABBOTT IRELAND

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Alinity - Primary ID 04U0001

Device Regulatory Overview

The Alinity (Model/Catalog Number: 04U0001) is a medical device manufactured by ABBOTT IRELAND. This product is indexed under FDA Product Code / Category Classification CHI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
04U0001
Product Code / EMDN
CHI
Device Name
Lipase2 Calibrator
Database Sync Date
2026-08-09 10:02:49

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Alinity?

The registered manufacturer of record for Alinity is ABBOTT IRELAND.

What is the Primary UDI-DI identifier for Alinity?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04U0001.

What classification code is assigned to this device?

This device is registered under product classification code CHI.

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