GUDIDData
gudid Primary ID: 5.0.2.5

InferRead Lung CT.AI (UDI 5.0.2.5)

Manufactured by Infervision Medical Technology Co., Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for InferRead Lung CT.AI - Primary ID 5.0.2.5

Device Regulatory Overview

The InferRead Lung CT.AI (Model/Catalog Number: 5.0.2.5) is a medical device manufactured by Infervision Medical Technology Co., Ltd. This product is indexed under FDA Product Code / Category Classification OEB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
5.0.2.5
Product Code / EMDN
OEB
Device Name
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.
Database Sync Date
2026-08-09 09:37:50

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 InferRead Lung CT.AI?

The registered manufacturer of record for InferRead Lung CT.AI is Infervision Medical Technology Co., Ltd.

What is the Primary UDI-DI identifier for InferRead Lung CT.AI?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5.0.2.5.

What classification code is assigned to this device?

This device is registered under product classification code OEB.

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