GUDIDData
eudamed_udi Primary ID: 06952804802905

COVID-19 Antigen FIA (UDI 06952804802905)

Manufactured by Assure Tech. (Hangzhou) Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for COVID-19 Antigen FIA - Primary ID 06952804802905

Device Regulatory Overview

The COVID-19 Antigen FIA (Model/Catalog Number: COV-S23F3) is a medical device manufactured by Assure Tech. (Hangzhou) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105099099 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
COV-S23F3
Product Code / EMDN
W0105099099
Device Name
COVID-19 Antigen FIA
Database Sync Date
2026-08-09 16:46:39

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 COVID-19 Antigen FIA?

The registered manufacturer of record for COVID-19 Antigen FIA is Assure Tech. (Hangzhou) Co., Ltd..

What is the Primary UDI-DI identifier for COVID-19 Antigen FIA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06952804802905.

What classification code is assigned to this device?

This device is registered under product classification code W0105099099.

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