eudamed_udi Primary ID: 04049016161530

ANA (HEp-20-10) IIFT (UDI 04049016161530)

Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ANA (HEp-20-10) IIFT (Model/Catalog Number: FA 1522-12010-R) is a medical device manufactured by EUROIMMUN Medizinische Labordiagnostika AG. This product is indexed under FDA Product Code / Category Classification W0102100101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: FA 1522-12010-R
Product Code / EMDN: W0102100101
Device Name: ANA (HEp-20-10) IIFT
Database Sync Date: 2026-08-09 16:51:59

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 ANA (HEp-20-10) IIFT?

The registered manufacturer of record for ANA (HEp-20-10) IIFT is EUROIMMUN Medizinische Labordiagnostika AG.

What is the Primary UDI-DI identifier for ANA (HEp-20-10) IIFT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04049016161530.

What classification code is assigned to this device?

This device is registered under product classification code W0102100101.

Similar Classification Devices (W0102100101)

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