GUDIDData
eudamed_udi Primary ID: 06974576209874

Fully automatic chemiluminescence immunoassay analyzer (UDI 06974576209874)

Manufactured by Guangzhou KOFA Biotechnology Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Fully automatic chemiluminescence immunoassay analyzer - Primary ID 06974576209874

Device Regulatory Overview

The Fully automatic chemiluminescence immunoassay analyzer (Model/Catalog Number: 2FF00005) is a medical device manufactured by Guangzhou KOFA Biotechnology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0201020102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
2FF00005
Product Code / EMDN
W0201020102
Device Name
Fully automatic chemiluminescence immunoassay analyzer
Database Sync Date
2026-08-09 16:49:15

Full Regulatory Attributes

๐Ÿ”’ 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 Fully automatic chemiluminescence immunoassay analyzer?

The registered manufacturer of record for Fully automatic chemiluminescence immunoassay analyzer is Guangzhou KOFA Biotechnology Co., Ltd..

What is the Primary UDI-DI identifier for Fully automatic chemiluminescence immunoassay analyzer?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974576209874.

What classification code is assigned to this device?

This device is registered under product classification code W0201020102.

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